Our client is currently seeking a contract role for a QA Specialist within the GSIUC QA Department's packaging and labeling support team. Responsibilities include QA approval/release of packaging components, review/approval of documents, and addressing GMP deviations. Strong knowledge of QA systems, methods, and proactive problem-solving skills are essential.
Job Responsibilities:
- Ensure compliance with regulatory requirements, contributing to the development and implementation of Standard Operating Procedures (SOPs).
- Review and approve SOPs and other controlled documents.
- Conduct QA review and release of packaging components and may assist with artwork approval.
- Identify deviations, assess impacts, and take appropriate actions.
- Review and approve GMP Deviation investigations, CAPAs, and master data for operations.
- Participate in data collection for QA metrics and compliance improvement projects.
- Support compliance audits and walkthroughs, ensuring adherence to GMP standards.
- Maintain programs for product quality and GMP compliance.
- Work independently on routine tasks and with general guidance on new assignments.
Knowledge and Skills:
- Preferably prior experience in the pharmaceutical industry, particularly in QA.
- Proficiency in Good Manufacturing Practices (GMPs) and QA principles.
- Familiarity with FDA/EMEA standards and quality systems.
- Basic knowledge of OPEX Lean tools and root cause analysis.
- Audit, investigation, and report writing skills.
- Strong verbal, technical writing, and interpersonal skills.
- Proficiency in Microsoft Office applications.
Typical Education and Experience:
Bachelor's degree with 3+ years of relevant experience in a GMP environment.
Prior experience in the pharmaceutical industry preferred.
Terms:
Fulltime, (12 month contract)
Salary:
Competitive Package
For a confidential discussion on this or any other current opportunity please contact Nicola Murphy on 021 233 9200 / nicola@logiskills.ie
IAC-Mar24