QA Manager/QP

CPL

Mayo

Opportunity for QA Manager/QP in the Mayo area. The Role: The QP will have QA oversight of all activities in the business unit ensuring the necessary GMP requirements are upheld. The QP will hold responsibility for certifying all batches manufactured in the business unit against the requirements of it’s marketing authorisation and the principles of GMP. The QP is legally responsible for batch disposition. The role will provide support to the Director of QA in addition to the Business Unit Leader in achieving the required goals and objectives; meeting customer requirements and the necessary regulatory requirements as laid down by the FDA, EU and regional Ministries of Health as relevant. Core Duties: Provide direction to all quality personnel based in the Business Unit, including QC, Product Release, Compliance and Microbiology. To agree with the Director of QA and Business Unit Leader the delivery of the company quality plan and global regulatory requirements providing appropriate, timely information as required. Anticipate, understand and address the changing regulatory environment of the Pharma/Medical Device industry. Assess quality implications of new regulatory guidance and implement necessary changes to business unit processes. Provide quality input for proposed process changes within the business unit. Manage quality requirements for New Product Implementation. Manage quality KPI’s. Provide quality input for all activities undertaken within the business unit. Represent the company in all business unit Ministries of Health inspections, ensuring the unit is audit-ready. Ensure any non-conformances and open commitments related to the business unit are addressed. The QP will approve all records generated by the business unit, including but not limited to batch records, laboratory certificates of analysis, deviations, validation documents and product quality review reports. Evaluate and disposition all batches manufactured in the unit. Provide guidance on all non-conforming material/deviated batches. Direct the investigation and determine the release disposition of such material/product. Direct the activities of the QA and Product release personnel within the business unit to ensure product is released and activities are undertaken in a compliant manner. Co-ordinate QMS Management. Attend all meetings as required or arrange an appropriate deputy. For example: Project Meetings. Departmental/ANDON Board/APEX Meetings. Financial. H&S. Quality Management & Senior Management review meetings; Site & WWQA. QMS: Deviation investigations & Change Control Review Board. Microbiology Trends. REQUIREMENTS. Proven track record in a quality discipline in the Pharma/Medical Device environment. Degree in a Pharmaceutical Science and recognised QP qualification. Clear understanding of working within a regulated environment. Excellent communication skills. Ability to use sound judgment to make effective decisions within appropriate timeframes. Interested candidates please contact Annette Murphy on 091 507515 or email annette.murphy@cpl.ie. This job originally appeared on RecruitIreland.com.

2564 days ago