- Reference: AJ46686
- Job Type: Permanent
- Location: Westmeath
- Category: Science, Pharmaceutical & Food
Quality Assurance Specialist Responsibilities:
The QA Specialist will be responsible for operational and compliance support for manufacturing operations, including review and approval of associated manufacturing and testing records. In addition, they will help maintain the site compliance program, supporting the supplier qualification program through supplier audits and site compliance through internal audits.
QA Essential Functions:
- Implement and oversee the quality systems.
- Represent Quality during manufacturing operations and be available to resolve issues and provide guidance in a collaborative fashion.
- Provide quality and cGMP input and oversight of the manufacturing facility including data integrity.
- Generate QMS Standard Operating Procedures (SOPs) to reflect these processes, which are easy to follow and promote both compliance and efficient operations, in accordance with facility requirements.
- Review and approve procedures, documents and records.
- Support the Deviation and OOS investigation systems, advising on assessing impact and approving final reports and associated CAPA.
- Support the site change control system, evaluating proposed change controls as assigned, making informed assessments of quality impact of changes.
- Support the facility Supplier Management program, including qualifications and re-qualifications of suppliers and materials, auditing vendors and providing oversight as required.
- Manage the QA responsibilities of external manufacturers of APIs, reviewing deviations and changes at the CMO site.
- Support site compliance program, performing internal audits, training internal auditors as required, and implementing audit action plans.
- Participate and follow-up in third party audits and/or inspections carried out at the site by the authorities or clients.
- Complete all required QMS assignments (CAPAs, investigations, actions etc) in accordance with agreed timelines.
- Perform production on the line AQLs, and the incoming inspection and disposition of raw materials, consumables, packaging.
Required Knowledge, Skills, and Abilities
- 5 -10 years’ experience working in finished product pharmaceutical / biologics manufacturing, including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas.
- Experience in participation in regulatory audits (HPRA or FDA) desirable.
- QC analytical experience desirable.
- Computer skills i.e., Microsoft Office, Windows etc. Experience in Reliance, LIMS & SAP would be advantage
- BSc in science discipline required.
- Lead auditor certification highly desirable.
- Qualified Person experience or educational requirements desirable.
For more information or to apply please contact Tina Egan on email@example.com 09064 78104.
Please Note: Collins McNicholas will not forward your details to any company without your prior approval.
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