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