Quality Assurance Associate - Pharmaceuticals - £30,000 - £35,000 + Benefits
We are currently working in partnership with an international pharmaceutical manufacturer to appoint an experienced QA Associate on an initial 6 month fixed-term contract basis at their facility in Co. Antrim.
- Perform PDQA (Pharmaceutical Development Quality Assurance) activities to support the development of products in compliance with Regulatory standards and business objectives.
- Manage and execute PDQA Project Plan activities.
- Maintain PDQA documentation.
- Observe and review development activities. To include manufacturing of development batches, testing of materials, process and methods validation, and tech transfer activities.
- Develop, implement and train on procedures as required in compliance with company standards.
- Participate on project CMC teams as PQQA representative and act as Point Of Contact for all Quality decisions.
- Liaise as required with external contractors performing development activities.
- Provide support for Pre-Approval Inspection's or development related inspections.
- Review and approve project related documentation to include, but not limited to, change controls, manufacturing protocols and records, specifications, certificates of analysis and stability tables.
- Ensure all OOS results and unplanned deviations are fully investigated and documented and any corrective and preventative actions are implemented.
- Review analytical validation activities so that these activities meet the required standards appropriate for the activity and phase of development.
- Create Quality agreements for development products with external suppliers based on corporate QA standards.
- Support the supply of Clinical supplies - providing PDQA checks on labels and protocols, release, distribution/IVRS issues and reconciliation as appropriate.
- Perform supplier qualification activities for materials and ensure data are collated and filed.
- Provide input and review product specification files.
- Provide Quality review of CMC regulatory submissions.
- Collaborate with commercial sites and external operations to ensure technical transfer is handled successfully.
- Undertake any other duties, which may be assigned by Senior Management.
- BSc in Life Science, preferably pharmacy, chemistry or biochemical science
- At least 1 years experience in a Quality Role in the Pharmaceutical Industry.
- Knowledge of risk-based approaches to Pharmaceutical Development
- Knowledge of cGMP Quality Systems
For further information please contact Craig on 02890242824 or submit your CV via the link.