Job Summary:
We are seeking a highly skilled and detail-oriented Senior Quality Engineer to join our team in the field of biopharmaceutical manufacturing. As a key member of our quality assurance department, you will play a critical role in maintaining the highest standards of product quality and regulatory compliance.
Key Responsibilities:
* Quality Assurance Oversight: Influence and oversee the Commissioning and Qualification (C&Q) of GMP assets, develop and maintain quality assurance procedures, conduct routine self-inspections, and investigate deviations and non-conformities.
* Regulatory Compliance: Stay current with industry regulations, assist in preparation and execution of regulatory inspections, and ensure products meet regulatory requirements.
* Documentation and Reporting: Maintain accurate quality records, prepare and review documentation related to product quality and compliance, and participate in risk assessments and quality improvement projects.
* Training and Development: Provide training to staff on quality-related procedures, stay informed about latest developments in biotechnology, and demonstrate initiative and continuous improvement mindset.
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, effective communication and teamwork skills, and demonstrated initiative