- JN -072022-1642391
- Feb 07, 2023
I am delighted to be collaborating with my client, a global biopharmaceutical company, seeking a Quality operations Manager to join their team in Waterford.
This is a permanent role within a company focused on improving patients' lives through research and innovation when it comes to drug products that treat autoimmune and severe inflammatory diseases.
This is an excellent opportunity to progress and develop your career in a company with major future growth. The Quality operations manager is responsible for ensuring the highest quality standards for product portfolios by managing the operation quality element in line with compliance and standards related to the company, cGxP, SOPs and regulatory guidelines.
The successful candidate will have a degree in science or engineering with 7+ years' experience working in a pharmaceutical manufacturing environment in a similar role with ideally 3 years in a sterile manufacturing environment. You will have experience with investigations, change controls and CAPAs. Excellent knowledge and experience in GMP and understanding of quality systems. People management experience desirable.
- Ensure review of all Quality and production batch documentation is completed correctly, to achieve a high level of customer service and cGMP.
- Ensure that Batch documentation, Laboratory results and related Quality System documentation is correct and approved prior to QA/QP release
- Supports preparation of any Submission Documentation to support licence applications
- Ensure SAP material changes are reviewed and correct prior to approval
- Ensure customer/contract services Technical Agreements are implemented and maintained according to established procedures.
- Continuously promote a positive safety culture.
- Provide support for the development, implementation, and maintenance of the Pharmaceutical Quality System and supplier management program.
- Provide support for management of complaints, deviations, CAPA's and change controls associated with commercial products.
- Provide operation and maintenance support of quality documentation system.
- Preparation of annual reports, annual product reviews and core documents.
- Support supplier qualification and internal quality review.
- Support Investigating out-of-trend/specification (OOT/S) reports.
- Conducting internal audits and/or coordinating the self-inspection program.
If this role is of interest, please 'apply now.'
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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