Job Overview: As a Senior Quality Engineer, you will play a critical role in maintaining the quality and regulatory compliance of biopharmaceutical products within our next-generation manufacturing facility.
Key Responsibilities:
* Influence and oversee Commissioning and Qualification (C&Q) of GMP assets, including review and approval of associated deliverables (protocols, drawings, test documents, etc.).
* Develop and maintain quality assurance procedures, policies, and systems.
* Conduct routine self-inspections and monitoring assessments to ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant regulations.
* Investigate and address deviations, non-conformities, and CAPA (Corrective and Preventive Actions).
* Stay current with industry regulations, guidelines, and best practices.
* Assist in the preparation and execution of regulatory inspections and audits.
Qualifications:
* BSc, Hons BSc, MSc, or PhD in Pharmacy, Science, Engineering, Quality, or related discipline.
* Minimum of 3-5 years of experience in quality assurance within a biotechnology or pharmaceutical manufacturing environment.
* Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management, and other biopharmaceutical regulatory requirements.
* Excellent problem-solving and analytical skills.
* Detail-oriented with a strong commitment to maintaining high-quality standards.
* Effective communication and teamwork skills.
* Demonstrated initiative – able to work proactively without direct supervision and with a continuous improvement mindset.
About This Role:
This position requires a highly motivated and detail-oriented individual who can work effectively in a team environment. The ideal candidate will have a strong understanding of quality assurance principles and regulatory requirements.
We Offer:
A competitive salary and benefits package, as well as opportunities for professional growth and development.
What We Look For:
We are looking for individuals who share our values and are passionate about delivering high-quality results.
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