Description
Senior Quality Specialist required to join a specialist pharmaceutical company located in Ireland. The position provides complete oversight as product steward for 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.
Role and responsibilities:
Provide oversight for CMOs and product lines, including but not limited to:
* Change management
* Investigations (process, complaint, and laboratory)
* Product release
* Annual Product Review
* Master documents (batch records, methods, labels, etc…)
* Validation protocols and reports
* Stability data review / stability coordination
* Audit results and assisting audit teams as assigned
* CAPA
* Identify, develop and execute project plans and timelines to achieve desired results
* Develop and manage quality information infrastructure
* Participate actively on cross-functional support and process improvement teams
* Become a technical expert in product
* Lead technical transfer activities as required to/from CMO’s
* Assist in the application of appropriate quality technology tools to establish and maintain process capability and to resolve process deviations and product failures
* Create, approve, and implement quality system procedures associated with the product realiasation process as well as procedures associated with CMO management and oversight
* Plan, execute and follow up on CMO site visits due to identified issues, validation/transfer activity or as routine periodic visits
* 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 CMOs and company with FDA and other regulatory body investigations and inquiries as needed
Minimum Requirements:
* Minimum BSc
* Biotechnology qualification a strong advantage
* Qualified Person status an advantage
* Minimum 5 years’ 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 an advantage
* Application of cGMP to manufacturing and testing
* Product release and investigations
* Self-motivated and self-managing.
* Able to identify, execute and prioritize work tasks/projects with an awareness of escalation responsibility as needed.
If this is you please apply today