VACANCY - Diomed Developments

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STABILITY MANAGER
Dermal Laboratories – Gosmore, Hitchin
Full Time
This is a great opportunity for a Stability Manager to join our successful
Pharmaceutical Company in Hertfordshire. This role will be based at the Company’s
site near Hitchin, where a wide variety of medicines and healthcare products are
developed. The successful applicant will be responsible for an existing team of
analysts who form the Stability team within the Pharmaceutical Development and
Support department.
Key Responsibilities:
 Management of all aspects of the stability programme and ensuring
compliance with internal procedures, industry regulations and regulatory
guidance documents.
 Implementing process improvements that drive benefits to efficiency,
effectiveness, compliance and robustness.
 Management of the stability team and their activities. Assure adherence of
acceptable cGMP practices by staff during execution of all work tasks.
Evaluate, develop and manage personnel performance.
 In support of the Laboratory Manager, assist in the preparation of various
stability summaries and reports, as well as authoring relevant stability
sections of regulatory submissions.
 Data review and trend evaluation, writing and evaluating investigations, and
addressing compliance challenges related to stability.
Skills:
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In order to apply for this position, you must hold a B.Sc. in a science field; an
advanced scientific degree is desirable, with some knowledge of statistical
analysis.
Previous experience in conducting stability studies is essential.
Experience with statistical applications for stability data evaluation and shelflife determination is required.
You must have 3-5 years of previous management experience, plus 5-7 years
of technical experience in a QA, QC or Manufacturing GMP environment in
the pharmaceutical industry.
Excellent working knowledge of GMP regulations for stability programmes
and laboratory applications, together with excellent teamwork, communication
skills and attention to detail. Strong technical and report writing skills,
particularly in stability protocols and summary reports.
Reporting to the Laboratory Manager, this is a full-time, permanent position.
If you are interested to find out more and apply, please contact Catherine
Beattie – telephone 01462 458866 or email your cv to [email protected]
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