Job Reference: JO-2007-65314_1596035452
Reporting to the Quality Director, you will lead, develop and co-ordinate the activities of the QA Operations Team; ensure finished products are produced in accordance with internal and external quality regulations (US, European, ROW GMP's and applicable regulatory filings.); accept or reject batches of finished products manufactured on the Cork site or subcontracted while maintaining an effective quality system including CAPA and Change control systems.
You will manage the activities of the site QP and to act as Qualified Person for the site when required, providing Quality Support for the Site and to contribute to the implementation and maintenance of Quality Assurance actions in compliance with the current GMP regulations.
- Approve all operational procedures/instructions specification & master production instruction with the potential to affect the quality of the product.
- Review & approve of validation protocol & reports, study protocol & reports to support Capital or key site projects as required
- Make sure that there is stability data to support retest or expiry date, storage conditions
- Support inspections and audits from external parties (e.g. FDA, IMB, EMEA or alliance partners).
- Participate in internal audits as required
- Preparation and review of regulatory dossiers.
- Establish and maintain support as key representative with Third-Party Managers
- Oversee quality systems such as (CAPA /ER report system, Change Review Board system etc.)
- Allocate the work of the department to ensure schedule adherence in alignment with site KPI's and shipping schedules
- Participate in the recruitment of new employees.
- Complete the Annual Appraisals of QA operations staff and ensuring stretch goals, and appropriate learning and development goals for each
- Partake in department budget management
- Manufactured bulk or finished products or purchased finished products in compliance with the cGMPs and licence requirements.
- Review production files, analytical files, origin of raw materials, and all appropriate documentation
- Establish a system to release or reject raw materials, intermediates, packaging, labeling materials and finished product.
- Ensure critical deviations are investigated and resolved
- Setting up a performance indicator to monitor adherence to release schedules
- Disposition of discrepancy reports.
- Ensure appropriate CAPA's are in place.
- Preparation and Approval of Annual Product Review (data collection, graphic analysis)
- Review and updating of the regulatory filing (US & European, DMF type 1…), with the collaboration of the regulatory department.
- Review and assessment of GMP critical systems
- Participate in technical and scientific meetings, in training days, trade fairs, conferences(technological intelligence). Provide to operations all guidelines and documents.
Education & Experience:
- Relevant 3rd level qualification
- Enroll or have completed education to meet the requirements for the position of Qualified Person as defined in Article 49 Directive 2001/82/EC
- Demonstrated ability in the leadership, management, and development of a team in a pharmaceutical area
- Previous management / supervisory experience essential
- Experience of GMP auditing and documentation
- Ability to critically assess issues and execute problem-solving
- Excellent communication and presentation skill
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