Job Description
The QA Lead QP will direct QA and Technical support concerning external suppliers of commercial semi-finished and packaged dosages, to ensure that products are manufactured and released in accordance with their licenses and principles and guidelines of current Good Manufacturing Practices. To manage and develop colleagues/reports within QA as appropriate.
Scope includes Active Pharmaceuticals Ingredient, Solid Oral Dosage, BFS, Packaging, Testing, and Distribution for Pharma product produced at the SM OPU CMOs.
Responsibilities:
Direct establishment and maintain a close working relationship with all CMOs for commercial drug product dosages.
Direct the SM OPU DP External QA Team (including QPs) to support QA activities (batch review and release, CMO site GMP support and Contractor GMP compliance) associated with manufacture/packaging/testing at CMOs
Provide appropriate leadership, direction and support for QA related projects and initiatives
Provide all necessary QA support for New Product Introduction into the commercial environment to ensure GMP issues are addressed during the transfer of product and technologies
Ensure that Quality Technical Agreements are established, maintained, implemented and revised regularly for all contractors according to company standards
Ensure CMO facilities are audited to ensure they have effective Quality Systems in place so that they are in compliance with the principles of GMPs and global regulations
Provide QA support to the Product Launches and new business opportunities, to ensure that GMP aspects are covered and potential quality issues identified
Direct any quality related investigations ensuring CAPA are implemented as appropriate
Direct change control evaluations for potential quality impact and development of appropriate change action plans
Support execution of QMS integration and remediation activities to ensure compliance is achieved and maintained
Be familiar with Controlled drug legislation and ensure that relevant manufacturing sites are compliant with local and requirements.
Ensure the SM OPU QA team meets targets for Quality Systems and CMO KPIs
Education & Experience Requirements:
? University degree in Chemistry, Pharmacy, Biology or other related scientific discipline
? Practical experience for typically 10-15 years in the Pharmaceutical industry in manufacturing / technical / QA or QC role(s)
? Good working knowledge of EU/US GMPs and with other major International GMP standards
? Demonstrated success in managing staff/working in global multifunctional teams
? Strong leadership and team development record.
? Successful inspections by global Regulatory Agencies.
Travel to CMOs as needed
Key Skills, Abilities, and Competencies:
? Excellent technical / QA background so can work very successfully with CMOs
? Ability to deal with difficult issues arising, develop and maintain excellent relationships with CMOs
? Logical problem solver of difficult problems
? Excellent communicator with good interpersonal skills
? Coordinator / Completer / Finisher
? Good self-starter
? Proven track record of successful relationships with Regulatory Agencies.
For further information on this QA lead / QP position please contact Laurentina Kennedy at The RFT Group on 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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