- Reference: GY43625
- Job Type: Permanent
- Location: Limerick
- Category: Science, Pharmaceutical & Food
As QA Specialist you will perform manufacturing record review, determine disposition of final product and ensure compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Standard Requirement Documents.
- Prepares appropriate documentation and executes release of acceptable product lots and vendor materials.
- Reviews completed manufacturing, filling, and labelling records, and analytical data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
- Reviews, edits, and approves deviation notifications, deviation investigations, and corrective actions.
- Reviews, edits, and approves change control and SOPs.
- Reviews, edits, and approves new and revised master manufacturing records.
- Reviews, edits, and approves validation protocols and executed protocol reports.
- Audits production and other departments for quality system effectiveness.
- Performs hands-on monitoring of production and non-production activities and notifies area and Quality Management of any observed non-compliance.
Skills, Experience and Qualifications:
- Requires BSc/BEng in scientific discipline or related field.
- 3+ years of relevant work experience in pharmaceutical or related industry. Biologics manufacturing experience highly desirable.
- Adaptable and flexible, willing to work shift as needed.
For a confidential discussion and more information on the role/company please send your CV by email to: email@example.com