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PQG Ref: 080702

Quality Assurance Manager
£63,881 - £78,723 (depending on experience)

Based in Elstree, Bio Products Laboratory (BPL) is a not-for-profit organisation managed on behalf of the Department of Health by a special health authority, NHS Blood and Transplant (NHSBT). BPL is committed to providing a competitive supply of high quality plasma-derived therapeutic protein products to the UK and overseas.

Reporting to the Technical Director you will manage the QA team to ensure that the quality system is maintained to current industry standards, subject to continual improvement and implemented throughout the organisation.

The successful candidate will have a proven track record of implementing and completing high level tasks, and will strive to promote the Quality Assurance System through all departments at BPL.

Other responsibilities will include:

• As the job-holder cited on BPL’s Manufacturing Authorisation as a ‘Qualified Person’ (QP), releasing product for sale, once satisfied that all GMP and regulatory requirements have been met

• Responsibility for compliance to legislation and GDP relating to wholesaling medicinal products

• Co-ordinating and hosting external compliance and regulatory inspections, for example MHRA inspections

• Establishing and maintaining systems for audit of those operations involved in the development, manufacture and distribution of BPL’s products

• Overseeing GMP training on site, and working with training co-ordinators and line managers to provide training programmes relating to GMP and QA

Click here to download a full Job Description. Click here to download a Person Specification.

Experience of management of QA systems in a pharmaceutical company approved by MHRA is essential, while experience of releasing sterile product manufactured aseptically and hosting MHRA inspections would be advantageous.

Applicants must be qualified and registered as a practicing Qualified Persons for purposes of release of human medicinal products. A biological background is preferred but not essential.
           
If you feel you have what it takes to make a value-added contribution to this key area of our business, please apply on our website www.bpl.co.uk by downloading an application form, and send to the HR department, Bio Products Laboratory, Dagger Lane, Elstree, Hertfordshire WD6 3BX, or email to:  vacancies@bpl.co.uk

Closing Date:                        28th July 2008

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PQG Ref: 080630

Quality Assurance Manager [QP status] External Supplies - East Midlands


Excellent salary & bonus, subject to experience, plus benefits package including relocation

Reckitt Benckiser is a hugely successful global FMCG company with revenues exceeding £5 billion. We hold a strong position in the FTSE 30 and are the name behind many market-leading household, health and personal care products. Ours is a fast paced multi-cultural working environment. We take pride in achievement and have a truly personal commitment to delivery.

Reporting directly to the Head of Quality Management, this post leads the QA External Supply Team, based in Nottingham and Hull, which is responsible for ensuring that Reckitt Benckiser Healthcare European Contractors, including the UK Distribution Centre, Active Ingredient Suppliers, Raw Material and Component Suppliers are approved, compliant with regulations and routinely deliver materials, components and products that meet the company’s and regulatory specifications plus Healthcare legislation. The role requires close working and influencing relationships with production related function teams across the company and the supplier base to ensure any possible risk of damage to either Reckitt Benckiser Healthcare or individual brand names is totally minimised.

Main Responsibilities & Accountabilities:

• Ensure the Contract and Supplier approval process and database is maintained. The approval process must support RB testing schedules for any items supplied, support any regulatory submission and ensure no major criticism on regulatory or customer audit of RB healthcare manufacturing sites.

• Ensure Contractor Technical Agreements and any Technical Files are maintained in line with RB policy and EU regulations

• Ensure API manufacturers are certified as GMP compliant or, in the case of active supply from a non-pharmaceutical source, continued use must be justified on the basis of identified areas of non-compliance and associated risk assessment. The justification has to be recorded and approved

• Supplier and Contractor initial and continued approval is risk based. Information will be gathered by a variety of means including, but not exclusively, by audit. The supplier audit programme will be generated on the basis of risk assessment

• Maintenance of Supplier quality performance indicators and input into the annual review. The performance indicators are used to support cross functional supplier improvement programmes. Performance measures are displayed to key functions, local business units and Global QA where relevant

• Responsible for ensuring the UK National Distribution Centre operates within RB policies and Wholesaler Dealer regulations.

• Maintenance of Distribution performance indicators related to UK Healthcare manufacturing operations and their contractors and action plans established to maintain improvement trends

• Ensure Auditor skills and competency profiles are maintained, at the correct level to ensure delivery of the audit plan, for all UK QM Department and, where applicable, personnel from other functions where applicable

With substantial pharmaceutical/associated industry experience and a Life Sciences degree, you will be eligible to be, or ideally, registered as a Qualified Person. A broad knowledge of pharmaceutical manufacturing processes, including sterile products, solid and liquid dosage forms, plus the EU regulations covering active ingredients, excipients and components are essential. The post needs good communication, presentation, influencing and IT skills – both in MS Office and role specific programmes, TDS, Q pulse/QIR etc.

You will be capable of dealing with pressured situations, taking, and communicating, decisions with senior management and cross functional teams where these impact on business performance and other targets. The ability to develop the quality systems/knowledge of others, to ultimately drive operational excellence within Reckitt Benckiser, is also required.

To join a uniquely confident, entrepreneurial, can-do culture, send your CV with covering letter which will be treated in strictest confidence, via e-mail to RB@tech-search.co.uk, quoting QAM-ES, or for a confidential discussion call Mike Butler on +44 (0)113 246 8786

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PQG Ref: 080520

QUALIFIED PERSON, South, UK

Salary and benefits: Very competitive, including excellent package

As one of the world’s largest providers of diverse development and manufacturing services to the global pharmaceutical industry, this expanding organisation is able to offer exciting, long term career opportunities.

UK based operations of this organisation are experiencing increasing demand from customers for products and services. Because of this, the requirement for a Qualified Person has arisen, to take ownership of QP activities for technologically novel approved and clinical trial products.

As part of a driven, collaborative quality team, you will work closely with multiple internal functions and diverse external customers to ensure increased quality standards, efficiency, customer service levels and business performance. You will be an influential member of the quality team, operating within a matrix structure, which includes production, development, sales & marketing, operational excellence, customer services and supply chain.

To be successful in this role, you will be a commercially aware quality professional, who has the ability to work within a well integrated and supportive QP team. Your experience will have been gained in either contract manufacturing, ethical pharmaceutical, nutritional, OTC or consumer health sectors. You will possess a degree in life science, chemistry or pharmacy and you will be qualified to practice as a Qualified Person. Newly qualified candidates will be considered.

In this role you will be responsible for batch release and resolving quality system issues to satisfy quality and regulatory requirements, while allowing the business to operate efficiently. As a QP you will be a natural role model, able to support an organisation to achieve objectives in-line with business requirements. Your skills will have ideally been developed in a lean driven environment.

You will have the opportunity to work with both internal and external customers, therefore your communication and relationship building skills need to be exceptional. The ability to build productive and successful relationships, whilst enhancing the image of a quality function is essential.

This opportunity offers the chance to join a talented quality team, in an expanding and very successful global organisation. Opportunities for CPD and overall career development are extensive.

To apply for this exciting role, please send your CV to info@wilsonalexander.com, or for further information, please contact Sam Hassall at Wilson Alexander on +44 (0)1753 850540. Please quote reference: SHQP-0508-PQG when applying. All applications will be treated with the strictest confidence.

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PQG Ref: 080519

Quality Systems Manager [QP status]
- East Yorkshire

Excellent salary & bonus, subject to experience, plus benefits package including relocation

Reckitt Benckiser is a hugely successful global FMCG company with revenues exceeding £5 billion. We hold a strong position in the FTSE 30 and are the name behind many market-leading household, health and personal care products. Ours is a fast paced multi-cultural working environment. We take pride in achievement and have a truly personal commitment to delivery.

Reporting directly to the Operational Quality Manager, this role controls UK Healthcare quality systems, including batch review and product release functions, ensuring that customer service targets are met and regulatory compliance is maintained.

In addition to being a QP you will lead and manage a team to produce, amend and maintain effective factory documentation, ensuring that the Quality Management system meets corporate and regulatory standards. Making release for sale recommendations for all in-house and approved contract manufactured product.

Role Responsibilities & Accountabilities:

• Ensures recording documents are compliant, minimum record of activities with secure links to electronic evidence of compliance where in use.
• Overall lead time from completion of production to clearance is displayed to Supply Management; this is an integral part in ensuring Customer Service levels are routinely delivered.
• To control, maintain and issue documentation for manufacture, compliant with the marketing and manufacturing authorisations requirements (MHRA, FDA and other regulatory bodies) for effective/efficient delivery of operational activities
• All standard operating procedures and documentation are current.
• Prompt training and competency activities associated with documentation and system changes must be in place.
• To ensure the documentation system is fit for purpose and subject to continuous improvement - use of photos and visual aids where possible.
• Ensure batch records are adequately reviewed, release recommendation made, documents and retain samples are securely archived.
• Supports discrepancy resolution and improvement programmes at National Distribution Centre.
• Ensures that non-compliant stock remains under quarantine until agreed resolution.
• Identifies opportunities and implements improvements to the factory Quality systems.

The ideal candidate will be a Qualified Person with at least 3, preferably 5, year’s pharmaceutical/associated industry manufacturing experience and a broad knowledge of pharmaceutical manufacturing processes including sterile products, solid and liquid dosage forms. You will have a good understanding of pharmaceutical document systems, word processing and document formatting skills, a working knowledge of IT systems and their validation and should be able to demonstrate where you have improved such systems in a previous role.

Good people management, leadership, communication and presentation skills are essential; as is the ability to work with, and influence, cross functional teams. You will be capable of developing others in quality systems/knowledge that will ultimately support and enhance Reckitt Benckiser operational excellence in quality, cost and service. High attention to detail is also vital, particularly to recognise areas where systems are not sufficiently robust, being able to identify solutions to improve systems. You will be able to present a clear process flow and display ways in which improvements could be made with existing or new technology.

To join a uniquely confident, entrepreneurial, can-do culture, send your CV with covering letter which will be treated in strictest confidence, via e-mail to RB@tech-search.co.uk, quoting QSM-QP, or for a confidential discussion call Mike Butler on +44 (0)113 246 8786

Area Quality Leader - East Yorkshire

Excellent salary & bonus, subject to experience, plus benefits package including relocation

Reckitt Benckiser is a hugely successful global FMCG company with revenues exceeding £5 billion. We hold a strong position in the FTSE 30 and are the name behind many market-leading household, health and personal care products. Ours is a fast paced multi-cultural working environment. We take pride in achievement and have a truly personal commitment to delivery.
  
Reporting to the Operational Quality Manager, this post supports compliance with Reckitt Benckiser’s Quality systems, Good Manufacturing Practice and regulatory licence requirements for a manufacturing group and assists with practical operational changes and improvements across the site. Operating as part of the Supply and Quality Management Teams the AQL is responsible for nominated product groups, overseeing routine releases, rejecting sub-standard product and preparing/dealing with inspections by the MHRA (annually), BSI (6 monthly) plus other global regulatory authorities.

Main Challenges & Accountabilities

• Leading the resolution of quality issues to the point of recording and recommending actions to area Production teams.
• Ensuring quality and production requirements are considered, without detriment to either.
• Making key operational quality decisions within the area and recommendations to the site’s QPs based on these.
• Ensures long term preventative actions are captured in AQIPs and that actions identified to support teams are completed on time and in full.
• Reviews line issues regarding quality to the point of quarantining material pending review, recommending stock write off if required. 
• Leading non-conformance investigations, reporting and reviews for both internal and supplier related issues
• Corrective and preventative action facilitator, including audit actions
• Change control review and assessment of risk for changes within the area
• Issuing monthly quality reports
• Completion of risk assessments for existing processes/new projects as appropriate
• Quality representative on all area new projects
• Assessment of specific GMP knowledge, overview on operational competency.
• Local control and approval of validation protocols

The ideal candidate will be a graduate with a degree, or equivalent, in chemistry, pharmacy or microbiology. You will have knowledge and experience of Good Manufacturing Practice and Regulatory standards, preferably acquired in a Pharmaceutical or closely related environment.  Excellent attention to detail, problem solving, communication and IT skills are all essential.

To join a uniquely confident, entrepreneurial, can-do culture, send your CV with covering letter which will be treated in strictest confidence, via e-mail to RB@tech-search.co.uk, quoting AQL1, or for a confidential discussion call Mike Butler on +44 (0)113 246 8786

 

 

 

__________________________________________________________________________________________________ PQG Ref: 080407

There’s so many ways we can save lives. And we’ve built a  new facility to prove it.

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PQG Ref: 080331

QUALITY OPPORTUNITIES at CATALENT

Catalent Pharma Solutions (formerly Cardinal Health Pharmaceutical Technologies and Services) is the leading provider of advanced technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer healthcare companies in nearly 100 countries. The company applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes.  Catalent employs approximately 10,000 at more than 30 facilities worldwide and generates more than $1.7 billion in annual revenue.

The Catalent facility located in Bolton UK specialises in the packaging of pharmaceutical supplies for Investigational and Commercial use.  A number of exciting opportunities have arisen within the Quality function as a result of internal staff movements and our continued drive for growth and continuous improvement.  If you are a Quality professional with relevant experience in the following areas, we would like to hear from you:

• General Quality experience supporting production activities in the pharma, food or other regulated industry
• Quality Assurance experience as a QA supervisor, QA officer or QA assistant
• Quality Management experience or a Qualified Person (directives 2001/20/EC or 2001/83/EC)
• Qualification / Validation

If you feel you can contribute in this key area within a fast paced environment, bringing with you new experience to help drive the new business forward, send a CV and covering letter stating salary expectations and a description of how you feel you can contribute to clinicalsuk.hr@catalent.com or HR Department, Catalent Pharma Solutions, Lancaster Way, Wingates Industrial Park, Westhoughton, Bolton, B15 3XX.

Closing Date: 25 April 2008

______________________________________________________________________________________________________ PQG Ref: 080212

Qualified Person (QP)

The UK side of an international commercial GMP joint venture, based in Elstree Hertfordshire, is looking for applications of interest from QPs with experience in cell culture facilities to take the responsibility for all aspects of quality management and training, either on consultancy or on a full-time basis.

This will involve the responsibilities for the management of the laboratory, training laboratory staff, quality control within the manufacturing and packaging department, the overseeing of the quality aspects of product development, and input into the validation processes involved in the commissioning of new equipment.

Please apply to:

Ian Graney,
CEO RMS Innovations UK Ltd.
Cephalon House, 8 Manor Park, Wildmere Road, Banbury, Oxon, OX16 3TB

igraney@neuro-technics.com

______________________________________________________________________________________________________ PQG Ref: 080208

Quality Control (QC) Manager

An exciting opportunity to head up a growing QC laboratory recently transferred to brand new facilities within an expanding Pharmaceutical manufacturing company located on the South coast. You will have the opportunity to work in a fast paced environment where you will be managing and developing a team of analysts to achieve company goals and objectives.

Reporting to the Associate Director GMP QA, you will manage a growing team of 10 staff (working on two shifts) responsible for QC functions such as Raw Material and FPS testing, method development, method validation, and contract laboratory services, GMP, GLP, Health and Safety.

Strong organisational and multi tasking skills are required to ensure products are tested in accordance with specification and communication is key at all levels of the business to ensure sales targets are achieved. Reporting to Directors will be required on a regular basis.

You must have a strong chemistry background and be fully competent and experienced in Quality Control. Previous management experience is essential and you must have the proven ability to develop teams of people. You will also be capable of performing under pressure.

This expanding company will provide you with sufficient challenge and opportunity to satisfy the most ambitious professional.

An attractive package is available for the successful candidate, including pension, healthcare insurance, 23 days annual leave.

Please supply details in a covering letter with CV along with salary expectations to Carol Greenway, Custom Pharmaceuticals, Conway Street, Hove, East Sussex, BN3 3L ______________________________________________________________________________________________________

 

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