Description
Quality Manager / QP, responsible for leadership of the Quality Department within the company team, based in Dublin. The position provides complete oversight of all contract manufacturing organisations (CMOs) and service providers.The oversight includes complete signature authority, with responsibility for escalating high risk issues to management. The position also acts as a consultant to management regarding compliance issues and may lead very large projects that could cross site or divisional lines. The incumbent will co-ordinate compliance activities / projects with key CMO and Company groups. The role also requires local office GMP management and responsibility and QP release of product.
Role and responsibilities:
* Certification and Release of Finished Product lot(s) in accordance with EU cGMP requirements
* Performance of the Qualified Person (Q.P.) role in accordance the legislative requirements
* Senior Oversight and Governance of all Product/Technical Transfer(s) with 3rd parties from a Quality perspective
* Authorisation and Approval of all Change Records, Validations and Qualifications
* Communication with Competent Authorities in relation to stockÃ?Â-outs, waivers, batch specific requests and replenishment notifications.
* Review and approval of all Regulatory Filings in conjunction with Director of Regulatory
* Approval of QP Declarations for API manufacturers
* Governance of all External and Internal audit programmes and plan, execute and follow up on CMO site visits due to identified issues, validation / transfer activity or as routine periodic visits
* Responsible for ongoing Compliance of all licenses
* Identify, develop and execute project plans and timelines to achieve desired results
* Participate actively on cross-functional support and process improvement teams
* Seek to identify and execute safety improvements and waste minimisation opportunities
* Serve as leading technical expert in one or more key quality or compliance areas
* Assist in the application of appropriate quality technology tools to establish and maintain process capability and to resolve process deviations and product failures
* Assemble information, develop the decision and rationale for material review board (MRB) and field alert report (FAR) decisions, including follow up investigation and summary documents for both FAR and MRB
* Support scorecard development, maintenance, reporting and action / project development from scorecards
Requirements:
* Qualified Person status required
* Minimum 5 years oÃ?Âf experience in a QA or equivalent role
* Extensive experience in cGMP systems, pharmaceutical manufacturing and testing, experience must include role(s) in a manufacturing setting
* Sterile manufacturing and/or biotech experience required
* Managerial or Supervisory experience required
Preferred experience including, but not limited to the following:
* Application of cGMP to manufacturing and testing
* Product release and investigations
* Change Management and CAPA
* Regulatory inspections / Regulatory Affairs
* Self-motivated and self-managing. Able to identify, execute and prioritise work tasks/projects with an awareness of escalation responsibility as needed.
If this is you please apply today.