Quality Assurance Specialist
Our company is a leading engineering consultancy with a strong presence in project management, talent solutions, and commissioning qualification and validation services. We collaborate with prominent life science & technology companies to deliver strategic projects.
Key Responsibilities:
* Ensure compliance with standards for marketed and investigational drug products leaving the site.
* Guarantee adherence to regulatory and company requirements for products and aseptic processes.
* Provide quality oversight for Operations, ensuring manufacturing aligns with site policies.
* Conduct quality reviews during aseptic processing, including observing interventions.
* Lead investigations related to non-compliance in product or manufacturing processes.
* Review and audit Batch Records and Manufacturing Logs.
* Complete quality reviews of operations documentation (SOPs, JSTMs, Risk Assessments).
* Perform Line Clearance activities and Incoming Raw Material checks.
* Support Stability Program by performing sample pulls and weekly checks.
* Maintain finished product status and administer Quality Logs (e.g., QA Hold, Sample Request).
* Drive continuous improvements and streamline processes for compliance.
Required Skills and Qualifications
* 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 highly desirable.
* Strong knowledge of regulatory requirements.
Benefits
* Competitive compensation packages.
* Opportunities for professional growth in a dynamic work environment.
About Us
We are dedicated to delivering exceptional results in a collaborative and innovative atmosphere. If you are passionate about quality assurance and committed to excellence, we encourage you to apply.