QA Compliance Officer
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| Job Type | Permanent |
| Area | Roscommon |
| Sector | QualityOperations & Manufacturing |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #2084 |
| Job Views | 623 |
- Description
- Do you have 2+ years GMP in a Quality function? Team Horizon currently has an exciting permanent opening for a QA Compliance Officer with our Client, who are a leading manufacturer of OSD Products in the Midlands.
Why you should apply:
The company manufacturers and distributers for speciality off-patent/generic pharmaceuticals across the UK, Ireland and international markets
Their portfolio of products is diversified across multiple therapeutic areas, with particular strengths in analgesics and anti-infectives.
Mainly niche, value-added products, which are complex to manufacture.
With a strong pipeline of new product development, the company continues to grow in each of their key areas
What you will bedoing:
Ensure all operations & documentation are fully compliant with license details and updated in accordance with relevant guidelines and directives for assigned products.
Develop work processes in conjunction with Compliance Manager and Release QPs, to aid the release of medicinal product batches.
Initiate and investigate non-conformances/Process investigations as required where issues detected. Track and investigate any assigned investigations and complete CAPA actions to agreed timeframes.
Review and approval of Third Party CMO Master Batch Records (Batch Manufacturing & Packing records, Validation/Stability Protocols and Report, Finished Product Specifications and End Of Shelf Life specifications) for assigned products.
Prepare and Manage Quality Metrics and tracking reports on a weekly/monthly basis (Open Items/QRG/Audit Steering) and record all minutes and follow up actions (prepare relevant slides/reports).
Review and tracking of validations associated with Contract manufactured products.
Complete Annual compliance reviews of Third Party CMOs manufacturing process, specifications, test methods, GMP licence, and validation status, Stability reporting and packaging specifications for compliance to the MA.
Support maintaining and improving the Quality Management Systems supporting the Pharma QMS and CMO activity and ensuring that all aspects of the Quality Management Systems are up to date with Current GMP requirements.
Assist as required during internal/external customers and competent authority audits.
Review change control for assigned products and bring changes to the change review board (CRB) as necessary.
Develop and maintain familiarity with applicable legislation, guidelines and current industry practice that impact GMP, the QMS and validation activities.
Assist with the coordination and planning of API, Contract manufacturer and internal audits (Via Audit steering meetings).
Track and review CMO Product Quality Reports (PQRs) for assigned products and ensure that these are consistently completed fully and on-time.
Complete risk assessments as required for key processes changes, new regulations and as required per NCR/CAPAs.
Liaise with other departments and contract manufacturers and test laboratories to ensure supporting data generated is provided in a timely manner.
What you need to apply:
Bachelors of Scientific degree, ideally in pharmacy, pharmaceutical sciences, chemistry
Third Level qualification preferably in a scientific discipline
A Working knowledge of quality systems requirements, HPRA, MHRA, EU regulations and ICH guidelines as they relate to Quality Assurance.
Experience and knowledge of GMP and associated regulations.
