- Batch Record Review & material release to ensure compliance with GMP requirements.
- Carries out tasks related to the administration of event management systems including Review & Approval of Event, Deviations, and Customer complaints.
- Carries out tasks related to the management of batch records design and approval.
- Carries out administration of the SAP Quality Management Module.
- Carries out tasks relating to the management of site change control systems.
- Compiles Annual Product Reviews.
- Supports all validation activities on site as described in the Site Validation Master Plan.
- Approves and compiles where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.).
- Supports system qualification and process validation activities.
- Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance
- Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site.
- Participates in the introduction of new process or modified process steps, as part of a New Product Introduction Team (NPI)
- Perform GMP audits on-site and vendor facilities as required.
- Carries out tasks related to the administration of site supplier approval process.
- Bachelor's Degree in a scientific/technical discipline required
- A minimum of 3 years' experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
- Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
- Demonstrated knowledge and application of industry regulations as they apply to quality, including those of FDA, IMB, EMEA and other authorities.
- Experience in auditing of external suppliers, contractors and vendors.
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