QA Compliance Officer
Roscommon, IE
12d ago

The Opportunity

Team Horizon is seeking a QA Compliance Officer. The role requires a flexible individual contributor who works well in a team environment, and has necessary skills to organize, communicate and manage day-to-day work activity.

The principal duties of the QA Compliance Officer is the successful completion of Product quality review, data tracking and trending and reviewing all Third Party manufacturing activities for compliance to the MA.

The Role

  • Ensure all operations are fully compliant with license details and updated in accordance with relevant guidelines and directives.
  • Review of internal documentation to ensure compliance with license details and relevant guidelines and directives.
  • Develop work processes in conjunction with QA 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).
  • Review and approval of specifications / methods, Validation protocols, reports, manufacturing documentation, SOPs / forms and change controls as required supporting CMO operations.
  • 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 company site 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 DCCV 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 and company manufacturing Product Quality Reports (PQRs) 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.
  • Assure a safe and compliant work place by adhering to all EH&S procedures and reporting any health and safety issues as required.
  • Facilitate personal development and employee engagement by completing performance appraisals and any resulting development plans.
  • Comply with all training requirements as required by the job function.
  • Liaise with other departments and contract manufacturers and test laboratories to ensure supporting data generated and provided in a timely manner.
  • The Person

  • 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 good manufacturing practises and associated regulations.
  • The role demands a well-organized approach, underpinned by the ability to communicate effectively with people at all levels, both verbally and in writing.
  • Reliability, IT literacy and the ability to plan and complete projects to set timelines is essential.

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