Job Description
GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client's needs. We have multiple projects that we support, and we are looking to add to our team, we are interested in talking to you if you fit the criteria outlined below: QA Compliance Specialist 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. Education & Key Requirements Third-level degree in a science, quality, or engineering discipline. 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. 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 We offer competitive compensation packages and opportunities for professional growth in a dynamic and innovative work environment. If you are a motivated QA Compliance Specialist seeking an exciting challenge in the biopharmaceutical industry, we encourage you to apply. To start the process click the Continue to Application or Login/Register to apply button below.