Quality Assurance Officer- Pharmaceuticals - Bootle, United Kingdom - Medley Pharma Limited

Medley Pharma Limited

Verified Company

Bootle, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

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 selfinspection 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 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.
Multitasking 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 £21,000.00 per year

Schedule: