Quality Assurance Manager - Pharmaceuticals

Quality Assurance Manager - Pharmaceuticals Bootle, Cumbria, North West England, England

Medley Pharma Limited
Full Time Bootle, Cumbria, North West England, England 33000 GBP ANNUAL Today
Job description

Responsibilities

· Implementing and maintaining QMS. Change controls, completing logs, QP notification. Trending, CAPA, Deviation, Risk management and Filing closure reports.

· Handling MHRA audit. Preparing and submitting compliance and Interim update reports.

· Batch release activities.

· Notifying QP on relevant issues like deviation, complaint, change control & OOS.

· Managing new products launch activities.

· Managing change of site activities.

· Managing operating licenses.

· Internal audits & Risk management

· Maintains product quality and release by enforcing quality assurance policies and procedures and GMP/GDP requirements.

· Collaborating with other members of management to develop new product and launch.

· Prepares quality reports by collecting, analyzing and summarizing information and trends.

· Completes quality assurance operational requirements by scheduling and minuting Quality Review Meetings.

· If required, perform audits of API sites, Contract Testing Laboratory, Release site and Warehouse and ensure recommendations are complied with.

· Perform self-inspection and ensure compliances.

· Requirements

A Degree in a Scientific (B.Pharm / BSc/ BSc (Hons) minimum or equivalent) discipline will be essential.

· Experience as a Quality Assurance Manager of 3 – 5 years in a pharmaceutical cGMP environment.

· Good understanding and knowledge of GMP and QA in a pharma environment.

· Proven problem solving methodology/skills for complex technical issues.

· Proven ability to understand and interpret process/ analytical data.

· Multi-tasking and priority/ time management skills are essential.
Excellent interpersonal skills with the ability to work as an individual or as part of a close working team and delivering on business objectives

Job Types: Full-time, Permanent

Salary: From £33,000.00 per year

Benefits:

  • Company car
  • Company pension

Schedule:

  • Monday to Friday

COVID-19 considerations:
Yes

Education:

  • Bachelor's (preferred)

Experience:

  • Quality Assurance: 5 years (preferred)
  • Quality Assurance Managers: 2 years (preferred)

Work Location: One location

Quality Assurance Manager - Pharmaceuticals
Medley Pharma Limited

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