Salary: Competitive salary package.
Job Description:
We are seeking a Senior Associate Quality for Computer Systems to join our team in a global cutting-edge biotechnology company. The successful candidate will play a critical role in maintaining the quality and regulatory compliance of biopharmaceutical products within our next-generation manufacturing facility.
Key Responsibilities:
* Maintain quality assurance procedures, policies, and systems.
* Conduct routine self-inspections and monitoring assessments to ensure compliance with cGMP and other relevant regulations.
* Collaborate with automation, IT, and production teams to ensure quality throughout the manufacturing process.
* Investigate and address deviations, non-conformities, and CAPA to maintain quality.
* Ensure compliance with periodic review, change control, deviation, backup, and archive processes for systems.
Required Skills and Qualifications:
The ideal candidate will possess a BSc, Hons BSc, MSc, or PhD in Science, Engineering, Quality, or a related discipline, along with minimum 3 years of experience in quality assurance within a biotechnology, pharmaceutical, or medical device manufacturing environment. Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management, and other biopharmaceutical regulatory requirements is essential. Excellent problem-solving and analytical skills are also required.
Benefits:
This role offers a unique opportunity to work in a dynamic and fast-paced environment, with opportunities for professional growth and development. Experience with quality management systems (e.g., TrackWise) and automation systems (e.g., DCS, DeltaV) is highly desirable but not necessary.
Others:
If you are a motivated and experienced quality professional looking for a new challenge, please submit your application for consideration.