Pharmaceutical Stability Manager – Hertfordshire
Jason at CK Science is currently recruiting for a Pharmaceutical Stability Manager to join a truly independent UK pharmaceutical company, focused on researching and developing novel dermatological treatments on a permanent basis.
The Pharmaceutical Stability Manager is responsible for managing all aspects of the stability programme and ensuring compliance with internal procedures, industry regulations, and regulatory guidance documents. As the process owner, the Pharmaceutical Stability Manager is responsible for implementing process improvements that drive benefits to efficiency, effectiveness, compliance, and robustness.
Your main responsibilities in this role will be to:
- Execute and manage the commercial and clinical development stability programmes and maintain compliance with both ongoing and new regulatory requirements
- Manage and facilitate completion of all stability-related tasks
- Review specification changes for product, API, and packaging components to assess impact to Regulatory Stability Protocols and revise protocols as needed using appropriate change management systems
- Interface with Manufacturing, Formulation and Analytical Development, QC, QA, and Regulatory Affairs regarding stability indicating methods, testing, and results
- Manage the stability team and their activities
- Assign work in LIMS, manage stability inventory, maintaining schedule of stability pulls, testing deadlines, and reporting deadlines
- Write/review/approve SOPs and work instructions
- Assist in the preparation of various stability summaries and reports as well as authoring relevant stability sections of regulatory submissions
- Ensure all cGMP stability data are managed and evaluated as described in relevant internal SOPs (including OOSs/ deviations)
- Provide assistance in OOS, OOT and LI investigations, both stability and QC related
- Complete corrective and preventive actions assigned by investigations or audit observations
- Evaluate and continuously improve stability systems, quality and compliance with regulatory requirements, best practices and guidance, and quality systems policy and procedures
You are required to have the following qualifications, skills and experience:
- Previous experience with conducting stability studies is essential
- Experience with statistical applications for stability data evaluation and shelf-life determination
- Previous management experience with extensive technical experience in a Quality Assurance, Quality Control and Manufacturing GMP environments preferably from the pharmaceutical industry supporting clinical or licenced products)
- Proven experience with various quality processes (e.g. investigations/deviations, CAPAs, change controls, etc.)
- Excellent working knowledge of GMP regulations for stability programmes and laboratory applications is required
- B.Sc. in a science field or equivalent. An advanced scientific degree is desirable with some knowledge of statistical analysis
If you are employed by this client you will be joining a reputable British pharmaceutical company that develops well known and widely prescribed products for the treatment of a variety of skin disorders, such as psoriasis, eczema, dry skin conditions and acne.
For more information or to apply for this Pharmaceutical Stability Manager position please contact Jason on +44 (0)1438 723 500 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now.
CK Science is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference ST32369 in all correspondence.