QA/Regulatory Manager (Pharmaceutical)

This is an opportunity to work for a well establish company in the Berkshire area. The position involves the management of technical team and responsibility for activities related to product release, Quality Investigations, Auditing, Change Control, Customer Complaints, CAPA and Raw Materials , Component Release and Regulatory affairs. Responsibilities will also include supervision, training and appraisal of QA personnel.

Key Responsibilities:

• Manage a technical team and oversee activities related to product release, Quality Investigations, Auditing, Change Control, Customer Complaints, CAPA, Raw Materials, Component Release, and Regulatory Affairs.
• Improve Quality Systems to enhance the efficiency of delivering technical information.
• Establish and maintain a compliant internal and external audit system, ensuring timely completion of audits.
• Coordinate and implement change controls, focusing on continuous improvement and conducting risk assessments.
• Supervise, train, and appraise QA personnel.
• Review and proactively assist in process capability studies and statistical techniques.
• Ensure adherence to company rules, regulations, HACCP plans, Quality Plan, procedure sheets, and work instructions, with a specific focus on Supplier Approval, Raw Material Approval, Labelling, Equipment Calibration, Customer Complaint Analysis and Management, etc.

Qualifications and experience

• BSc, MSc in Chemistry, Biochemistry, or related discipline.
• Several years of experience as a QA/Regulatory Affairs scientist in pharmaceutical/medical device manufacturing or similar industries.
• Proven track record of working in a GMP/GLP environment.
• Demonstrated knowledge of document control systems and auditing processes, with familiarity in MHRA and FDA regulations.
• The QA/Regulatory Manager will have an excellent communication skill for effective collaboration with staff at all levels.

This position comes with a competitive salary and the opportunity to work with a highly successful team.

Key Skills:

GMP, QA, HACCP, CAPA, Management, Compliance, Auditing, Regulatory Affairs.

To apply for this position, candidates must be living in the UK and eligible to work.