​Mantell Associates is partnered with a global CDMO, who are searching for a Specialist to join their Quality Assurance and Compliance team.

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Senior Quality Assurance & Compliance Specialist - Responsibilities:

• Create, review, and approve documents including standard operating procedures

• Work with Manufacturing and Project Engineers to develop inspection and test methods and related acceptance criteria

• Assist with Quality Assurance reviews of processes

• Provide metrics reporting and status updates to Quality management relating to the facility (PD lab, GMP Facility and QC)

• Management of all documents, manual and electronic documents using Master Control

• Provide daily QA support for general operation activities, calibration status and preventive maintenance status of equipment and system in PD and QC laboratory and GMP Facility

• Support continuous improvement and oversight of Quality management System

• Work within a culture of continuous improvement and system efficiencies

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Senior Quality Assurance & Compliance Specialist - Requirements:

• Minimum of Bachelor's degree in Biology of Chemistry (or related)

• Experience in a Quality Assurance position within a highly regulated industry

• Relevant GMP experience in a Pharma/Biotech company, working within quality system and regulated GMP environment

• Strong understanding of quality control standards and testing techniques

• Knowledge of cGMP/ICH/FDA/EU regulations and guidance

• Proficient in using Microsoft applications (Microsoft Word, Microsoft Excel, Microsoft PowerPoint)

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​​Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.