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Quality Assurance Associate - £30 - £35k

Location Larne, County Antrim
Sector
Job Type Contract
Salary £30000 - £35000 per annum + Benefits
Published about 1 year ago
Start Date ASAP
Contact Craig Smart
Job Ref BLU0004587p

Job Description

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.

Role:

  • Perform PDQA (Pharmaceutical Development Quality Assurance) activities to support the development of products in compliance with Regulatory standards and business objectives.
  • Responsibilities:
  • 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.

Requirements:

  • 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.

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