QA Associate |Negotiable
Non Healthcare
Management
Permanent
South East

QA Associate

 

Additional Information

 

Location: Oxford

Salary: £35,000 – £40,000

Hours: 10am-6pm

Job Type: Permanent

Report to: Site Quality Assurance Manager

 

Summary

 

  • Works closely with manufacturing staff to ensure the unit meets customer expectations on delivery and product quality.
  • Responsible for release of product from the system.
  • Responsible for supporting production in the review and post compounding check operations.
  • Responsible for data set up In Merlin
  • Responsible for implementation and management of the companies quality system within the compound unit. Ensuring regulatory compliance.
  • Ensure that unit is compliant with all corporate quality system policies and procedures.
  • Responsible for review of the implementation of the companies Quality System to initiate, and drive continuous improvement

 

Key Responsibilities

 

  • Review, Post Compounding check and Release
    • Responsible for the Review of prescriptions on Merlin
    • Carrying out post compounding checks when required
    • Responsible for release activities associated with products manufactured at the compounding units.
  • Change Control
    • Maintain a local change control process to ensure all changes are fully documented
    • Ensuring all changes are assessed for risk and impact prior to implementation
    • Ensuring that all changes are completed fully as per impact assessment and in the appropriate time frame
  • Validation
    • Management of the site Validation Master Plan
    • Ensuring all equipment used for the manufacture and storage of product is validated before use
    • Ensuring all equipment used for the manufacture and storage of product is re-validated as required per the validation master plan.
    • Responsible for Approval of validation protocols and reports
  • GMP and Facilities and Equipment Control
    • Ensure that a schedule of environmental monitoring is in place that complies with GMP and that any out of limits or alerts are investigated and actions taken to correct.
    • Responsible for ensuring the schedule of microbiological monitoring ensures the product is safe to use, including ensuring a schedule and facility map are in place and that all testing is complete
    • Investigation of out of limits results using exception and CAPA processes
    • Ensuring all measuring equipment that may have an impact on product quality are calibrated to traceable standards
  • Quality System Measurement and Review
    • Chair monthly quality review meetings
    • Ensure outcomes, decisions and actions of the review are documented
    • Ensure meeting actions are completed to agreed deadlines
    • Report monthly quality KPI to UK QA Manager
    • Track and trend on a monthly basis quality system data and indicators, including but not limited to Exceptions, Errors and Complaints. Trending should include timeliness in completion as well as actual numbers
  • Complaints
    • Ensures all incidents reported by customers are appropriately documented and investigated
    • Management of complaints using the pilgrim PMDA software
    • Responsible for reporting any complaints that may result in Field Corrective Action immediately to the Business management representative and also the European FCA gatekeeper
    • Reporting any adverse events to Pharmacovigilence and the Business management representative

 

Requirements:

Education

Science degree e.g. Pharmacy, Chemistry, Microbiology or equivalent

BTech- Pharmaceutical Science or equivalent work experience

English GCSE or equivalent

Experience

Breadth & Depth of experience 2 years experience of working in a aseptic compounding operation
12 months experience of quality system implementation
Field of expertise: Ideally experience in all or any of the following:
Quality system management and implementation
Environmental / microbiological control
Validation
Risk management

 

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