Posted on 17/06/16
RHL, specialists in Technical, Engineering & Scientific talent acquisition, are currently recruiting for;
Title: QA Manager
Contact: Alex Butcher
Reference No: 226227
Overall Purpose of the Job: Responsibility for the Quality Assurance of aspects of a new API manufacturing facility. Development and implementation of a QA programme to provide assurance that’s products manufactured, tested and delivered to customers are in compliance with GMP’s and regulatory requirements.
Main Responsibilities: • Develops and coordinates QA programme for API manufacturing facility, to ensure continuous production of products consistent with GMP & regulatory requirements (MHRA/FDA). • Assures that products, processes, facilities & systems conform to quality standards and governmental regulation. • Conducts internal audits to monitor production processes, facilities and systems. • Conducts audits/reviews for raw materials suppliers. • Reviews and approves operating procedures in manufacturing and quality control departments. • Assures equipment calibration programmes complies with GMP requirements • Coordinates interdepartmental activities. • Develops and monitors budget. • Management of QA Officers and QA Administrators.
Person Specification - Essential Qualifications • Relevant degree/post graduate degree or equivalent professional qualification
Experience • 5 years related experience in QA, preferably in a bulk API manufacturing environment • Experience of managing a QA department • Experience facing audits, ensuring operations functions are followed • Experience with validation activities and drug master files in CTD format • Experience of GMP essential
Knowledge • GMP compliance and ICH Q7 guidelines
Please apply to Alex Butcher, Managing Consultant; email@example.com; 01233 658018 Recruitment Holdings Ltd (RHL) act as an Employment Business and as an Employment Agency.