Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met by following internal standards set out. Partners with other Departments to ensure that compliance systems are implemented in an efficient manner.
- 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 the administration of the SAP Quality Management Module.
- Carries out tasks relating to the management of site change control systems.
- Compiles Annual Product Reviews.
- Approves and compiles where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.)
- Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance
- Coordinates and assists in the preparation for regulatory and customer GMP inspections of the site.
- Perform GMP audits on-site and vendor facilities as required.
- Bachelor's Degree in a scientific/technical discipline required
- A minimum of 3 experience in quality ops, 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.
- The ability to operate as part of a team is critical.
- Customer focus
- Excellent communication skills both written and verbal
- Attention to detail
- Good problem-solving skills
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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The Life Science Specialists