Senior PDQA - Larne - Permanent
Grafton Recruitment, in partnership with a globally recognised pharmaceutical manufacturer, is currently seeking an experienced Pharmaceutical Development Quality Assurance Associate to join their expanding organisation at their Larne based site on a permanent contract.
Responsible for supporting development projects to ensure they are in compliance with company policies and regulatory expectations, and to act as the PDQA contact for development activities on CMC teams. Execute and lead Quality initiatives at the Larne site in response to new regulatory guidance.
Perform PDQA activities to support the development of drug products and combination products in compliance with Regulatory standards and business objectives. Champion new quality initiatives at the Larne site.
- 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 business standards.
- Participate on project CMC teams as PQQA representative
- 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 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.
- Lead project teams in implementing new quality initiatives at the Larne site.
- Support the development of combination products.
- Undertake any other duties, which may be assigned by Senior Management.
- Understanding of the pharmaceutical development process and associated ICH guidelines.
- Knowledge of cGMP Quality Systems.
- Knowledge of Combination Product guidance documents e.g. 21 CFR Part 4
- Knowledge of IS013485.
- Proven experience of working in a quality organisation with a focus on and understanding of development activities.
- Science qualification required (preferably pharmacy, chemistry or a related science).
- Knowledge of US and EU GMP guidelines, to include their implementation and interpretation in CMC product development.
- Experience or desire to gain experience, of auditing development CMC and clinical supplies activities.
- Experience of pharmaceutical manufacturing and analytical procedures, processes and validation.
- Ability to write and manage Quality Agreements.
- Good verbal and written communication skills. Ability to present effectively to groups and to get key points across.
- BSc in Life Science, preferably pharmacy, chemistry or biochemical science
- Experience working within a cGMP environment
- Experience with Microsoft, Excel, power-point etc.
- Knowledge of Code of Federal Regulations 21 Parts 210 & 211
- Knowledge of Code of Federal Regulations 21 Part 4 and part 820 & ISO13845
- Knowledge of risk-based approaches to Pharmaceutical Development
- Experience working within a cGMP environment in the Pharmaceutical Development area of the Pharmaceutical Industry.
In return you will receive a highly attractive annual salary, pension, 33 days holiday and flexible working hours. For further information please submit your CV via the link or call Craig Smart on 02890242824.