- Reference: JLS QAM
- Location: West Wales
- Salary: £50000 Negotiable
- Type: Full time
- Start: asap
Just Life Sciences are seeking a suitably qualified QA Manager for a leading Bio Pharmaceutical company in West Wales.
The company has brand new Laboratories and manufacturing is planned for Mid 2020.
We are looking for a candidate who has managerial experience and can mentor new staff and develop existing staff into creating a dynamic QA Team which will be fit for future growth within the Group.
Whilst the role will evolve as the Group does, your remit initially is to ensure regulatory compliance, appropriate documentation (fit for purpose) and that any actions from any QMS process are completed in the agreed time frame. Manage the overall performance of the Quality Assurance group.
Qualifications, Skills and Experience
- Key Duties and Responsibilities include:
- ·Manage the Quality Assurance group, its priorities, reports, performance and compliance to budgetary constraints.
- ·Manage the Quality Management System (QMS) and ensure its fit for purpose and in line with Regulatory expectations.
- ·Ensure the QMS is subject to continuous improvement.
- ·Review and approve Batch Records
- ·Perform Batch Release
- ·Ensure the QA team have efficient, effective processes to ensure the Group are compliant as reflected in regulatory and customer audit findings.
- ·Assist in the development and tracking of Quality Metrics. Prepare metrics for Management Review and Annual Product Quality Review.
- ·Review and/or approve Quality Events, CAPAs, change control in an efficient manner to ensure adequate and timely closeout of these.
- ·Performing both Internal and External audits.
- ·Part of the Quality Leadership team.
- ·Manages Complaints, Recalls and Returns.
- ·Manages the Supplier Management Process.
- ·Support the preparation, co-ordination and management of Regulatory and Customer audits.
- Qualifications and Experience Required
- ·Minimum Degree in Science (BSc or equivalent)
- ·Minimum 5 years’ experience in the Pharmaceutical (or related) industry
- ·Experience of team management
- If you are interested in this or any other position within a Life Sciences business then please email firstname.lastname@example.org
Just Life Sciences
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