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Job Description
GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services.
We are seeking a QA Manufacturing Specialist for the Sligo region.
**Job Summary:** We require a QA Manufacturing Specialist to ensure adherence to standards for marketed and investigational drug products, guarantee compliance of products and aseptic processes, and provide quality and compliance oversight for Operations.
Key Responsibilities:
- Ensure adherence to standards for both marketed and investigational drug products leaving the site.
- Guarantee compliance of products and aseptic processes with end-user, regulatory, and company requirements.
- Provide quality and compliance oversight for Operations, ensuring manufacturing aligns with site policies.
- Conduct quality oversight during aseptic processing, including observing aseptic interventions.
- Lead/assist in investigations related to non-compliance in product or manufacturing processes.
- Review and audit completed Batch Records and Manufacturing Logs.
- Complete quality reviews of operations documentation (SOPs, JSTMs, Risk Assessments).
- Perform Line Clearance activities and Incoming Raw Material checks.
- Provide Stability Program Support, including sample pulls and weekly checks.
- Maintain finished product status and administer Quality Logs (e.g., QA Hold, Sample Request).
- Lead daily walkarounds of manufacturing areas.
- Drive continuous improvements and streamline processes for compliance.
- Offer support as needed.
Essential Requirements:
- Third-level degree in a science, quality, or engineering discipline.
Job Skills/Experience Required:
- Minimum three years' experience in quality/operations in a regulated GMP environment.
- Aseptic processing experience in quality or operations is highly desirable.
- Strong knowledge of regulatory requirements.
Skills:
- High attention to detail and mental concentration for accuracy and compliance.
- Total commitment to quality and maintaining high standards.
- Demonstrates integrity, strong work ethic, and supports compliance with cGMP and HPRA/FDA regulations and company policies, procedures and guidelines
Job Type: Full-time
Experience:
- Manufacturing: 1 year (required)
- Biologics: 1 year (required)
- Quality assurance: 1 year (required)