Pharmaceutical Quality Manager
1 month ago
**Job Title:** Pharmaceutical Quality Manager
Location: Cambridge
Clinical Professionals Limited is a leading provider of pharmaceutical and medical device development services. We are currently seeking a highly skilled Pharmaceutical Quality Manager to join our team in Cambridge.
About the Company:
- Clinical Professionals Limited is a renowned expert in the field of pharmaceutical and medical device development.
Key Responsibilities:
- Lead design control and risk management activities for combination product development programs, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.
- Support and facilitate effective risk management activities at external design companies and manufacturing facilities related to assigned projects.
- Ensure combination product development activities are compliant with quality and regulatory standards, both internal and external.
Requirements:
- BSc in appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline) with a minimum of 2 years of relevant experience in the pharmaceutical combination product and/or device industries
- OR MSc in appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline) with a minimum of 2 years of relevant experience in the pharmaceutical combination product and/or device industries
- OR PhD in appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline)
- History of working in accordance with the requirements of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation
- Understand Good Manufacturing Practices (GMP)
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