Job Adverts

Ref: 20111220-1W


QC Laboratory Manager

A QC Laboratory Manager is required to lead and manage a team of 7 analysts in a small but fast-growing pharmaceutical company based in the South East of England.

The QC Department supports the Production departments, stability studies, and provides additional support for the Development departments and quality investigations.

Ideal candidates will have a BSc in Chemistry (or equivalent) and have experience in managing or supervising an analytical laboratory in a GMP environment encompassing Pharmacopoeial and in-house testing. Experience in stability, method validation and troubleshooting for various analytical techniques such as HPLC, GC, IR, and UV is essential. Empower experience would be beneficial.

The laboratory is responsible for the analysis of pharmaceutical raw materials, active ingredients, and finished products to ensure that they comply with internal and regulatory specifications. Chemical analysis, stability testing, protocol writing, and checking analytical data in accordance with cGMP are all within the scope of the role.

Key duties and responsibilities will include:

  • Providing leadership and management within the department through a structural process of objective setting, performance appraisal, and individual development.
  • Improving the overall department productivity and efficiency
  • Ensuring all QC operations are carried out in accordance to cGMP
  • Reviewing and approving analytical data & results, ensuring that they comply with internal and regulatory specifications
  • Ensuring robust training and self-inspection programs within the laboratories, as well as the review of SOPs, investigations, specifications, methods, validation reports, and cleaning verification reports
  • Implementing new procedures
  • Maintain the risk-based and scientific-based quality system as part of the Quality Unit
  • Establishing and maintaining efficient workflows to ensure operational excellence
  • Facilitation of method transfers

Applications from Qualified Persons are welcomed in order to provide on-site coverage to the main company QP.

All applications to be received by Friday 13th January 2012.

To apply please send your CV and covering letter to:

Crissy Clark
GW Pharma Ltd
Building 114
Porton Down Science Park
Salisbury
Wiltshire
SP4 0JQ

or by email to: ca@gwpharm.com

Ref: 20111212-1W



Pharmaceutical GMP and QP Tutors

RSSL is a specialist scientific organisation based on campus at the University of Reading, offering training, consultancy, analysis and research.

For over a decade, delegates have praised our well respected training programmes in GMP. Earning similar praise, our modular Qualified Person course has an outstanding record of success for those who go on to take the viva. Delegates favour our informal, practical and focused approach to the subject matter.

Courses are run at our dedicated training facility in Reading, or ‘in-house’ at a client site, when they can be tailored to a company’s own requirements.

We are now seeking additional tutors to support our business, so that our delegates can continue to benefit from the pragmatic and in-depth knowledge that experienced professionals are able to bring.

We are looking for professionals who are experienced in GMP and Qualified Person activities, with the enthusiasm and personality to enhance our team. Applications will be particularly welcomed from present or former QP assessors who are able to make the commitment to our programme.

For an informal chat about the course programme and what being a tutor for RSSL means to you, call Lyndsey Wright [Head of RSSL Training] on 0118 918 4165.

To see the range of courses and more information about RSSL training visit our website at:

http://www.rssl.com/services/pharmaceuticalandhealthcare/training/Pages/training.aspx

To apply please send a current copy of your CV or request for an application form to Lyndsey.wright@rssl.com

 Ref: 20111208-1W



QA Pharmacist

Greater Manchester, Bolton area

Full time Salary £36,000 to £38,000 per annum

Part of a long established and reputable company in the pharmacy industry, Middlebrook Laboratories is an exciting new venture. Continually developing new initiatives to better serve patients and maintain our reputation for delivering excellence, we are now introducing a brand new purpose built Specials Production Facility to manufacture and supply specials products to pharmacies, with a view to achieving rapid expansion.

We can therefore offer a fantastic opportunity for you to be involved in this thrilling project.

Job purpose:

  • Work within the Quality Management systems at Middlebrook Laboratories to maximise quality and efficiency and ensure compliance with current regulations for all medicinal products managed by the facility.

Key Responsibilities

  • Release of finished products manufactured in the Clean room
  • Approval of raw materials and wholesale specials or special obtains handled by the unit
  • Reporting and recording fails, reworks and other non-compliance
  • Operate CAPA system, recording out of specification and deviation events, etc
  • Managing documentation system
  • Coordinate, write, manage to resolve customer complaints, recalls, change controls, ensuring proper root cause analysis, prompt responses/ resolution
  • Generate or assist in the generation or review of SOPs.
  • Dealing with suppliers regarding quality enquiries for raw materials
  • Validating equipment
  • Providing technical expertise to the customers
  • Utilise scientific sources in order to work on improving quality of products and services
  • Generate supplier audit documentation and technical agreements, and help in preparation of external audits.
  • Participate in the internal audit programme to ensure continued cGMP compliance of all site activities.
  • Generate, assist in the generation or review of other technical documents, raw materials specifications, qualification documentation, validation documentation
  • Sampling Raw materials
  • Liaise with suppliers in order to obtain documents needed for internal Quality Approval
  • Advise and assist manufacturing staff when requested to do so.
  • Plan and carry out research projects appointed by the Quality Manager
  • Interact with customer services in order to improve operations and quality of services
  • Keep up to date with changing regulations.
  • Collate data on aspects of the quality management system for incorporation into regular periodic reports.
  • Participate in quality improvement initiatives.

Requirements

  • GPhC Registered
  • Minimum 2 years post register experience
  • Previous experience of working in a Quality field is essential.
  • Experience of working in a GMP environment in the pharmaceutical industry involving specials products is preferable.

Competencies

  • Experience of operating within a Quality Management Systems
  • Able to write SOPs
  • Oversight of Quality Management Systems
  • Strong IT system application skills 

If you are tempted by this opportunity, please email your CV to Joanna Kurek

 

 Ref: 20111110-1W 

 
QUALITY ASSURANCE & REGULATORY SCIENTIST

Astellas Pharma Ltd., Egham, Surrey

Astellas is one of the top 20 pharmaceutical companies in the world, employing 14,000 people globally. As a young and forward-thinking company, Astellas is dedicated to improving the lives of people around the world through the introduction of innovative and reliable pharmaceutical products. Astellas Pharma Ltd (APL) is the sales and marketing affiliate for the UK market and currently employs over 250 people. Its key areas of focus are transplantation, urology, dermatology, anti-infectives and pain management. 

This is an excellent opportunity to join a global pharmaceutical company and be part of the successful Regulatory Department in the UK. To join our team you will have a scientific degree or equivalent, a good eye for detail and the ability to work with little supervision. Excellent verbal and written communication skills are a necessity. Previous QA or Regulatory experience is ideal. 

Key duties and responsibilities will include: 

  • Set up and maintain the affiliate Quality Management System (QMS) based on global and EU policies.
  • Ensure that all deviations reported to or discovered by affiliate operations are investigated and suitable CAPA plans issued.
  • Escalate any discovered significant quality events to Quality Assurance Europe.
  • Ensure that any required market recalls are executed promptly and efficiently.
  • Ensure that Quality Agreements are established and maintained between affiliate and applicable supply sites or support departments.
  • Ensure that GMP/GDP audits are conducted at agreed frequency for all distributors and any repackaging partners.
  • Generate an annual Affiliate Management Review report at end of each Financial Year. Issue an action plan based on output of this Review report.
  • Preparation and maintenance of artwork for marketed products, ensuring compliance of artwork in packs.
  • Responsible for the timely preparation, submission (via MHRA Portal) and follow up of variations, renewals, and other regulatory applications to ensure maintenance of marketing authorisations and wholesale dealers licences.

If you’d like to know more about, or apply for this position, please send your CV and a cover note to recruit@eu.astellas.com, quoting Ref No: CPQA01. 

 Ref: 20111103-1W 



 

DIRECTOR of QUALITY ASSURANCE

Jamjoom Pharmaceuticals – Jeddah Saudi Arabia.

This is an exciting opportunity to join a rapidly growing research based International Pharmaceutical company having a new State of the art manufacturing facility for producing sterile products and Soft gel capsules. 

The ideal candidate will need to have a masters degree in a scientific discipline or equivalent and a minimum of 10 years experience in working in a Pharmaceutical GMP environment . 

The appointed person will have a high profile role leading and directing the Company’s quality Operations programs. This will include ensuring compliance of the Saudi-FDA regulated facility which manufactures a number of high quality generic commercial products for both local and international markets. 

The required incumbent will be an accomplished quality professional with a demonstrated management experience having a progressive approach to foster an environment of continuous improvement while ensuring regulatory compliance. Will be constantly advising and adopting new developments in local as well as international regulations and industry best practices to continually improve upon the Company’s quality Operations function 

Key duties and responsibilities will include: 

  • Establish and maintain a risk-based and scientific-based quality system to protect the public health and to meet Company’s business needs.
  • Through a quality system approach, ensure all GMP operations are in compliance, while maintain an efficient workflow to facilitate the operational excellence.
  • Establish and maintain an efficient and complaint validation program including process validation, cleaning validation, computer software validation, and instrument qualification.
  • Provide leadership and management within the department through a structural process of objective setting, performance appraisal, and individual development. By improving individual performance and group collaboration, the Director will be responsible for improving the overall department productivity and efficiency.
  • Oversee, and be ultimately responsible for, the Company’s quality Operations program. This includes overseeing and assisting with the Company’s training and auditing programs, as well as the review of SOPs, investigations, specifications, methods, validation reports, cleaning verification reports, analytical reports, and manufacturing records.
  • Audit the manufacturing facilities of vendors, customers and outside contract organizations.

For further Information; 

Please contact John Jolley 

by e-mail; John Jolley 

by mail; 38a London Street, Whitchurch, Hants. 

Telephone; 01256 895100 

Mobile; 07770447045 

 Ref: 20110907-1W 

 

 

 


 

The Jenner Institute – Clinical Bio Manufacturing Facility (CBF)

Quality Assurance Manager

Salary Scale Grade 8: (£36,862 – £ 44,016) per annum
(With a discretionary range up to £48,096)

The Clinical BioManufacturing Facility is the University of Oxford’s GMP (Good Manufacturing Practice) manufacturing facility, where the basic research into vaccines can be translated into an Investigational Medicinal Product (IMP) used in first in man clinical trials.We are seeking to recruit a Quality Assurance Manager to be responsible for ensuring all quality and regulatory aspects can be met whilst ensuring the smooth transition of novel academic research vaccines into the highly regulated manufacturing environment CBF. You will be responsible for the continuous improvement and streamlining of quality functions at the CBF whilst ensuring quality and patient safety remain at the heart of the organisation. 

You will have a life science degree or equivalent with a proven track record in a similar role (ideally as a named person on a MHRA authorisation) with biopharmaceutical / biotechnological experience gained in industry. In addition you should have prior experience of regulatory inspection, internal and external audits and managing and controlling documentation. Excellent organizational skills, the ability to work independently and as part of a team, and an ability to communicate and develop effective working relationships with a wide range of staff at all levels, internally and externally (academic collaborators, contractors and the regulatory authorities) are all required. You must be able to work under pressure and under strictly defined regulatory and safety conditions whilst maintaining a high degree of accuracy. You must have an adaptable approach to work and a willingness to tackle a variety of tasks. Good record-keeping skills are essential. 

Further informal information can be obtained from contacting Sarah Moyle or Eleanor Berrie on Tel: +44 (0) 1865 744845. 

The post is available for 2 years in the first instance. 

Only applications received before 12.00 noon on Friday, 16th September 2011 can be considered. You will be required to upload a CV and supporting statement as part of your online application. 

To apply for this role and for further details, including a job description and person specification, please click on the link below: 

https://www.recruit.ox.ac.uk/pls/hrisliverecruit/erq_jobspec_version_4.jobspec?p_id=100926 

 

  

Ref: 20110802-1W 

 

  

Boehringer Ingelheim ranks amongst the world’s top 20 leading pharmaceutical corporations. With nearly 41,000 employees in 47 countries we are a global team sharing knowledge and ambition to foster a healthier life.  

In the UK and Ireland together we are creating excellence, living our principles of pride, valuing people and trust and we are proud to have been placed in the Sunday Times 100 Best Companies to Work for Survey 2011.

 

Local Pharmaceutical Complaints Officer

– Competitive Salary + Benefits

Bracknell, Berkshire

This is an excellent opportunity to join a prestigious global pharmaceutical company and be part of a successful Regulatory Affairs department. Reporting into the Head of Regulatory Affairs, the successful candidate will ensure that the handling of product complaints for products marketed in the UK, Ireland and Malta is timely, effective and comprehensive. Working closely with the Drug Safety department, you will assess and report all technical complaints, document and forward returned samples to the appropriate manufacturing or packaging site and ensure all final reports are available to the complainant in a timely manner. 

To join our team, you will have a life science or medical related degree, accompanied by working knowledge and experience of the Pharmaceutical and Healthcare industry. An awareness and an understanding of Quality Assurance is ideal but a good eye for detail and the ability to work unsupervised in an accurate and efficient manner is an essential requisite. Excellent verbal and IT communication skills are also a must. 

Your contribution to Boehringer Ingelheim will be rewarded with a competitive salary and a range of outstanding benefits, including: Bonus, Pension, Healthcare, 25 days annual leave, a clearly defined career progression policy and development opportunities associated with a leading global pharmaceutical organisation. 

If you believe that this is the next career move for you, please visit our careers website, http://www.bicareers.co.uk/ and apply online. 

We are an equal opportunities employer.