Job Description
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
A third-level degree in a science, quality, or engineering discipline is required. A minimum of three years' experience in quality/operations in a regulated GMP environment is also necessary. Aseptic processing experience in quality or operations is highly desirable. Strong knowledge of regulatory requirements is essential. The successful candidate will have high attention to detail and mental concentration for accuracy and compliance. A total commitment to quality and maintaining high standards is expected, as well as integrity, a strong work ethic, and support for compliance with cGMP and HPRA/FDA regulations and company policies, procedures, and guidelines.