PJ Personnel currently seek an Associate Director Quality Assurance based in Mayo, Ireland. The Qualified Person 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 its marketing authorisation and the principles of GMP. The QP is legally responsible for batch disposition and must be listed on the company’s manufacturing authorisations. 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.
KEY/ACCOUNTABILITIES:
People
- Motivate the Unit’s employees to ensure all activities are performed in a GMP compliant manner through effective communication. Articulate the necessary quality requirements for the Business Unit in a clear, concise and persuasive manner.
- Provide direction to all quality personnel based in the Business Unit, including QC, Product Release, Compliance and Microbiology
- Provide guidance to all business unit functions to ensure activities are completed in a GMP compliant manner.
Strategic
- 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
Management
- 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.
- Participate in the business unit APEX activities providing quality input
- 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.
KEY 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.
