Jobs
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PQG Ref: 20100709-1
What do you envisage your future? At GE Healthcare, our vision involves looking at Healthcare in a completely new way. Focusing on earlier, pre-symptomatic disease detection and prevention, instead of late diagnosis. Helping clinicians access more information and interview sooner with targeted treatments so their patients can live longer, fuller lives.
We are looking to expand our Quality Assurance (QA) team at their Gloucestershire facility, which specialises in Aseptic manufacturing and lyophilisation of sterile cold kit diagnostics products. The Gloucestershire facility is a key player in the Company’s Medical Diagnostics business, which provides an inspiring range of products, and services to better diagnose, treat and manage patients with conditions such as cancer and cardiovascular disease.
QA Specialist
Ref: 1056186
This key role will focus on engaging all employees in ensuring continued compliance and facilitating a culture of continuous improvement. Reporting to the QA Director, utilising GMP knowledge and experience of sterile pharmaceutical manufacturing, the natural progressions for candidates in this role would be to Qualified Person training. Specifically, the role includes:-
- Complaint analysis, reporting and resolution
- Assessment of Quality System & participation of the self-inspection program
- Contribution to and assessment of change control requests
- Support and assessment/approval of the procedures and protocols/reports within the site Documentation system
- Ongoing development and delivery of cGMP employee training
- Interface and communicate with regulatory Affairs concerning Manufacturing and Marketing Authorisations
- Ensure completion and implementation of corrective actions arising from corrective & preventative action systems, Regulatory & internal audits
- Review of Product manufacturing batch documentation
- Influence quality system metrics such as CAPA, training metrics, completion, complaint resolution metrics, etc.
Successful candidate will be degree educated in a relevant scientific subject, and have gained Supervisory experience within the Quality Assurance arena. Sterile pharmaceutical manufacture and quality system auditing experience is highly advantageous.
To find out more and submit your details, please go to our website and search under the relevant job number.
---your Life. Your careers. Your purpose, Re-imagined---
Closing Date for this post: 30th July 2010.
You must be legally authorised to work in the UK.
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PQG Ref: 20100708-1
Pharmaceuticals / Pharmacovigilance / Clinical Trials
(Morpeth)
£50,000 - £55,000 + Benefits
Our clients adhere to ethically sound, innovative and value-driven practices in their diverse business ventures and initiatives. Their Morpeth site is part of the Pharma Solutions division, and is fully integrated pharmaceutical manufacturing facility producing active chemicals and pharmaceuticals with conversion into final sales packs in preparation for dispatch to more than 100 countries worldwide.
Due to significant growth they are now looking for a Quality Manager with a proven track record in people management to join us at their Morpeth site.
They are looking for an individual with a hands-on approach, who can lead from the front mentoring the team to achieve set goals, driving continuous improvement and professional development of the group.
Within this role you will mentor your team to achieve set goals whilst driving continuous improvement and professional development of the Group. You will host audits and use your analytical skills to solve complex problems, offering a different perspective, making Quality Operations see the world differently. This is an excellent opportunity to really bolster your experience in a range of manufacturing environments and with a range of dosage formats.
This opportunity is for an experienced Qualified Person to join this international organisation who is adept in active pharmaceutical ingredients and solid dosage forms with proven vendor management skills. Candidates with previous experience in steriles, EU importation experience, investigational medicinal products, clinical trial services and pharmacovigilance are particularly welcome.
networx are not a typical agency. We manage applications on behalf of our clients. After applying for this role you will be sent an email - it is essential you read this in order to complete your application. Please note, unlike a traditional agency we do not hold a database of candidates so will not contact you about other roles
Please email your CV together with a covering letter, to Sarah Nichols
Account Manager, or telephone 01943 467766 for more information.
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PQG Ref: 20100520-1
(Bolton)
M&A Pharmachem is looking for an experienced Quality Control Manager to be responsible for provision of analytical testing services within the business. Previous management experience is essential and you must have the proven ability to develop a team of people through strong organisational and communication skills.
The role will be responsible for all aspects of QC testing of pharmaceutical products and ensuring that the business is compliant with GLP/GMP/MHRA requirements. The candidate must have extensive practical knowledge of:
- Staff management and development within a busy QC Laboratory environment
- Pharmacopoeial analytical methodology (including HPLC, GC-MS, AA and UV)
- Analytical, process and cleaning validation methodology
- ICH Stability Testing Protocols
- Annual Product Quality Reviews
- Self Inspection Audits.
Key responsibilities are:-
- to ensure that Product Release Testing deadlines are met.
- to manage and monitor the implementation of cGLP/Health & Safety and Quality Systems within the Laboratory.
- to manage new product development testing in support of marketing authorisation applications.
- to proactively take part in Quality Improvement Initiatives
- to take part in audits performed by Regulatory Bodies
Based in the North West, M&A Pharmachem is a leading UK own brand and contract manufacturer of generic solid dose products. This role offers the candidate the opportunity to grow with a rapidly expanding business and be involved in key decision making as a member of the Senior Management team.
You should be educated to Degree Level or equivalent in a science related subject (Chemistry, Pharmacy or Biology) and have a good command of the English language and grammar, along with strong analytical skills. You must be self-motivated, computer literate, a team player and be able to work in a demanding and busy environment.
The role will report directly to the Technical Manager/Qualified Person. The salary is negotiable dependant upon experience. Please email your CV together with a covering letter, quoting your salary expectation to jjefferson@mapharmachem.co.uk or contact John Jefferson Tel: +44(0) 1942 816184 for more information.
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PQG Ref: 20100401-01
Qualified Person / Quality Assurance Manager
Overton, Hampshire
This is a full time position within a small, Overton based, Pharmaceutical company.
You must have previous experience with all aspects of QA and QP activities, including product release, GMP, product quality reviews and technical transfers. You should be educated to Degree Level or equivalent in a science related subject (Chemistry, Pharmacy or Biology) and have a good command of the English language and grammar, along with strong analytical skills. You must be self-motivated, computer literate, a team player and be able to work in a demanding and busy environment.
Please telephone 01256-772730 for an application form.
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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.
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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