Our client is seeking a contract QA Specialist supporting Packaging and Labelling Operations. The role involves QA approval and release of primary and secondary packaging components, review and approval of packaging and labelling documents, procedures, and GMP deviations. Requires strong knowledge of quality assurance systems, methods, and procedures (12-month contract)
Job Responsibilities:
- Develop and implement changes to Standard Operating Procedures (SOPs) and controlled documents.
- Review and approve primary and secondary packaging components and artwork.
- Identify deviations, evaluate impact, and determine appropriate actions.
- Review and approve GMP Deviation investigations and CAPAs.
- Review and approve Master data and recipes for operations.
- Participate in data gathering for QA metrics and compliance improvement projects.
- Assist with compliance audits and walkthroughs.
- Work with secondary packaging contract organizations on QA document reviews.
Knowledge and Skills:
- Experience in the pharmaceutical industry, preferably in QA.
- Proficiency in current Good Manufacturing Practices (GMP).
- Knowledge of FDA/EMEA standards and quality systems.
- Familiarity with OPEX Lean tools and root cause analysis.
- Strong audit, investigation, and report writing skills.
- Excellent verbal, technical writing, and interpersonal skills.
- Proficiency in Microsoft Office applications.
Education and Experience:
4+ years of relevant experience in a GMP environment with a BS degree.
3+ years of relevant experience with an MS degree.
Prior experience in the pharmaceutical industry preferred.
Terms:
12-month contract, Full-time
Package:
Negotiable
For a confidential discussion on this or any other current opportunity please contact Nicola Murphy on 021 233 9200 / nicola@logiskills.ie
IAC-Jun24