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Job Details

Director, Quality Assurance

Company: EPM Scientific
Location: New Haven
Reference: JEAO1207171113
Closing Date: 21 Dec 17
Type: Permanent
Salary (£): 100,000+
Benefits:

Job Summary:

An expanding biotechnology company that offers clinical services and software with applications ranging from tissue to humans is seeking an experienced QA professional to oversee...

Requirements:

An expanding biotechnology company that offers clinical services and software with applications ranging from tissue to humans is seeking an experienced QA professional to oversee the management and operations of the company-wide QA program for Chemistry.

Responsibilities:

  • QA review and approval of production records, process documentation, procedures, components and methods to ensure production and release requirements are met.
  • Evaluate, implement, and approve SOPs, protocols/methods to inspect and test in-process raw materials and finished products for compliance with QA and regulatory requirements
  • Review OOS/Deviations
  • Oversee QA Associates for Chemistry
  • Review CMC section of IND prior to submissions

Qualifications:

  • Strong GMP, GCP, ICH, FDA knowledge in a QA environment
  • Experience hosting FDA audits, and conducting vendor audits
  • B.S or advanced degree in Chemistry or related scientific field
  • 21CFR Part 212 preferred 

Apply for this job: Director, Quality Assurance

Contact Information:

Address:  Head Office
Ground Floor 21 Lombard Street London
EC3V 9AH
England
Tel:  +44 (0)20 3758 8855
Website:  Visit Our Web Site

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