Overview

Quality Assurance Manager

Quality Assurance Manager – Pharma – Cambridge/ King's Lynn / Bury St Edmunds/ Norwich

My client is a leading pharmaceutical organisation who are looking for an experienced quality manager with extensive pharmaceutical experience to join their team on a permanent basis. The candidate will responsible for leading a large fast paced QA department. This role is a fantastic opportunity for candidates with experience leading or managing smaller teams to step up to a department head or to gain further experience managing a small team. Focussed on site based projects the role will also have interaction with business wide quality projects. If you are a QA professional working in the pharmaceutical sector looking for a new challenge within a great team then apply now via the website or call Joseph Tiffin on (Apply online only) for more information.

Essential Duties and Responsibilities

Lead, manage and develop quality systems staff within the compounding unit ensuring all staff reporting to the position are provided with the training and development needed for them to complete their jobs effectively providing coaching and mentoring
Responsible for implementation and management of the Quality System within manufacturing
Ensures that the manufacturing is compliant with Manufacturing license, MHRA and EU GMP requirements, customer requirements and standards and policies
Support Quality Management Reviews through trending and reporting of applicable Quality Management System metrics and data.
Track and trend quality system data and indicators, including but not limited to NCR, CAPA, CQI, Complaints, Micro OOL, Service Complaints.
Report weekly / monthly / quarterly quality KPI to Senior Management.
Support continuous improvement of systems to track and trend quality system data and indicators, including timeliness in completion as well as actual numbers.
Oversees the calibration program on site to ensure on time completion of scheduled calibration tasks.
Adhere to Environmental Health & Safety (EHS) policies, procedures and requirements.Qualifications

Degree level or equivalent in Pharmaceutical, Biotechnology, Chemistry, Microbiology / Engineering or extensive experience of supporting quality assurance departments in a management capacity
Experience in line management in a quality position or similar is a requirement
Experience of working in a highly regulated environment
Experience working In Quality Systems within a leadership position
Pharmaceutical, Medical Device, Biotechnology, Chemistry, Microbiology or other related regulated industry experience essential
Proven knowledge of Quality System processes, with working knowledge of current EU and UK GMP requirements
Experience of coordinating and supporting Document Control, Internal Audit, CAPA, Non-conformance and Complaints processes
Working knowledge and hands on experience of software tools to manage Quality Systems processes such as Trackwise or similar systems