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.
Ensure that internal and external quality standards are adhered to (cGMP/Regulatory requirements) for commercial product
- 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
- Making 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).
- Participating in internal audits as required
- Participate in the preparation/review of regulatory dossiers.
- Establish and maintain support and key liaison representative with Third Party Managers
- Oversee key quality systems such as (CAPA /ER report system, Change Review Board system etc..)
Managing the QA Operations Team:
- Allocating the work of the department to ensure schedule adherence in alignment with site KPI's and shipping schedules
- Participating in the recruitment of new employees.
- Completing the Annual Appraisals of QA operations staff and ensuring stretch goals, and appropriate learning and development goals for each
- Partaking of department budget management
Ensuring the Release or rejection of batches of (including oversight of QP to perform the following
- Manufactured bulk or finished products or purchased finished products in compliance with the cGMPs and licence requirements.
- By reviewing:
- Production files
- Analytical files
- Origin of raw materials
- And all appropriate documentation
- By establishing a system to release or reject raw materials, intermediates, packaging, labelling materials and finished product.
- By making sure critical deviations are investigated and resolved
- By setting up a performance indicator to monitor adherence to release schedules
- By dispositioning of discrepancy reports.
- Ensuring appropriate CAPA's are in place.
To meet Internal & External cGMP Requirements
- Preparation and Approval of Annual Product Review (data collection, graphic analysis…)
- By participating to the review and updating of the regulatory filing (US & European, DMF type 1…), with the collaboration of the regulatory department.
- By reviewing and assessment of GMP critical systems
- Participating and follow-up the audits and/or inspections carried out at the site by the authorities or clients.
- Participate in technical and scientific meetings, in training days, trade fairs, conferences… (technological intelligence…). Provide to operations all guidelines and documents.
Participate in the development of the Quality department and the quality standard across the site.
- Participate in the generation of initiatives and action plans for the development of QA operations and improvement of GMP compliance across the site.
- Participate in the achieving of QA objectives and quality plans.
- Participate and follow-up of audits and/or inspections carried out at the site by the authorities or clients
Education & Experience:
- Relevant 3rd level qualification
- Enrol or have completed education to meet the requirements for 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.
- Excellent communication and presentation skill
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