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To advertise here contact for details. _____________________________________________________________________________________________________

PQG Ref: 20100223-1

HEAD OF QUALITY/QUALIFIED PERSON (Chester)

Medifill UK are looking for an experienced Head of Quality/Qualified Person to be responsible for quality in the business including QC, QA and regulatory affairs. Previous management experience is essential and you must have the proven ability to develop teams of people through strong organisational and communication skills.

The role will be responsible for release of pharmaceutical products to market and ensuring the business is compliant with cGMP/MHRA requirements. The candidate must have experience of pharmaceutical manufacturing, an extensive knowledge of laboratory testing techniques (including HPLC) and practical experience of test method validation and product quality reviews. The salary is negotiable dependant upon experience.

Key duties include:-

- Qualified Person (QP) responsibilities as defined in EU Directive 2001/83

- To manage and monitor the implementation of cGMP and Quality systems throughout the business

- Ensure that the manufacture and release of pharmaceutical products by the Company is carried out in accordance with the Marketing Authorisations held for each product and in compliance with regulatory guidelines

- Managing MHRA and client audits

Medifill is a contract manufacturer of a range of pharmaceutical liquid products, including oral, topical and metered dose pump sprays and has grown rapidly since start of pharmaceutical production in 2006. Medifill continues with rapid growth and this role offers the candidate the opportunity to grow with the business and as a key member of the Senior Management team be involved in key decision making. The role will be challenging and will offer rewards for an ambitious and focused senior manager.

The role will report directly to the Managing Director.

Please send your CV together with a covering letter, quoting your salary expectation to david@medifilluk.com or contact David Bytheway Tel: +44(0) 1244 837090 for more information

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PQG Ref: 20100125-1

Oxford BioMedica develops gene-based medicines for the treatment of cancer and neurodegenerative disease and we are now looking to strengthen our Quality Assurance team with the following position:
Quality Assurance Officer
Ref: OB10-02

You will undertake a variety of Quality Assurance based duties including: maintaining the Deviation and Non-compliance management system, co-ordinating CAPA follow up for all OBM products; tracking all GXP related change control requests; interacting on QA matters both internally with project, clinical and regulatory teams and externally with GMP contractors involved in the manufacture, testing and distribution of IMPs; coordinating close-out of supplier audit findings; maintenance of documentation to facilitate QP batch release inclcluding Product Specification Files; tracking of Clinical Trial Materials (CTM) distribution and disposition; planning of ongoing and prospective CTM supply with internal project and clinical teams; plus supporting the in-house GMP training programme .

The successful candidate will ideally have Quality Assurance experience preferably in a pharmaceutical GMP setting and be educated to at least HNC level in a relevant scientific discipline.

We offer attractive salaries aimed at attracting the best people with recognised relevant experience. We offer a share option scheme, life assurance, generous holiday allowance, childcare voucher scheme, health cash benefit plan, company pension scheme and a friendly working environment.

To apply, send your CV and a covering letter to: HR Manager, Oxford BioMedica (UK) Limited, Medawar Centre, Oxford Science Park, Oxford OX4 4GA.

hr@oxfordbiomedica.co.uk

Closing date for applications is 22nd February 2010 No agencies.

Please see our website for more information: www.oxfordbiomedica.co.uk

 

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PQG Ref: 091026-1

QUALIFIED PERSON
and/or QUALITY CONTROL MANAGER

Custom Pharmaceuticals is an independently run facility for contract manufacturing, packaging, analytical and technical services for tablets, capsules, powders and granules for the Pharmaceutical and Healthcare industry.

We are looking for either a QP/Quality Manager or a separate QC Manager and QP to join a dynamic quality team based at our Moulsecoomb site (Brighton).

Reporting into the Quality & Compliance Director, you will manage QC resources in order to meet company goals and objectives and act as a QP for release of products to market. Other duties include managing audits, ensuring product compliance and ensuring that the QC team test raw materials in accordance with specifications.

You must have a strong chemistry background and be fully competent in Quality Control systems. Previous management experience is essential and you must have the proven ability to develop teams of people. Strong organisational and communication skills are essential to ensure ‘right first time’ processes and sales targets are achieved.

This expanding company will provide sufficient challenge and opportunity to satisfy the most ambitious professional. The salary is negotiable and benefits include pension, private medical insurance, 31 days holiday and life assurance.

To apply for the position please send your CV and a covering letter, detailing salary expectations, to the HR Department, Custom Pharmaceuticals Ltd, Conway Street, Hove, BN3 3LW or email hr@custompharm.com.

Please indicate on your application which position you are applying for.

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PQG Ref: 091008-1

For us, Quality solutions are Key...

Quality Assurance Specialist

Idis is a niche company with a passion for meeting patients unmet clinical needs, through connecting patients and healthcare providers with pre-approved medicine, working in partnership with pharma and biotechs, providing strategic supply solutions and comparator drug planning and sourcing.

Idis is currently looking to expand the well established QA division with a Quality Assurance Specialist, who will be charged with ensuring the successful implementation of QA solutions. As an organisation Idis is extremely ethical and our suppliers adopt the same high standards and ethical principals.

The successful applicant will have:

• Proven ability of working in dynamic environments with a high degree of customer/supplier interaction
• High energy, self motivated with a strong sense of purpose and clarity of vision
• Proven experience of working successfully within a QA Specialist role
• Proven ability of successful Internal and External audit management
• Proven experience of identifying remedial, preventive and corrective QA solutions,
• Experience of writing SOPs and training
• Proven experience of an excellent process and documentation change control implementation
• Preferably experience of being a lead Pharmaceutical assessor
• Capability of working autonomously in a quality driven organisation

In return you will be joining an entrepreneurial and dynamic organization where the line of sight to the customer is at the heart of everything that they do and achieve. Idis is passionate about what they do – a sales led organization, achieving customer excellence with integrity. Your positive contribution is integral to making a real difference to Idis success.

You will receive career development, a competitive salary and a wider benefits package which includes a performance related bonus, pension, private healthcare and life assurance.

For further information and to review the full job description please contact Daniel Jones at Hays Pharma on +44 (0)207 922 7115 or alternatively you can email him at daniel.jones@hayspharma.com

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