Quality Officer - Compliance and Process

Position: Quality Officer - Compliance and Process Support
Location: South Wigston

Quality Officer – Compliance and Process Support - FTC

15-month fixed term position, 5 days/week, 37 hours per week, Office Based

An opportunity has arisen with our client to join their Quality Assurance team, reporting to the Principal Quality Officer – Compliance and Process Support

The purpose of this role is to act as the primary QA Liaison for the Sterile Manufacturing facility for marketed and investigational medicinal products. To work with Sterile Manufacturing to ensure the facility maintains compliance with GMP, ISO 13485, US Code of Federal regulations (21 CFR), Medicines Regulations 2021 as amended and internal procedures.

Responsible for management of Quality Systems and compliance within the Sterile Manufacturing department including:

* Instigating, investigation and review of Quality Incidents and GMP deviations

* Regular Gemba walks of manufacturing units to ensure compliance with internal processes and regulatory standards

* Assisting microbiology with investigation and assessment of GMP deviations.

* Review of Out of Specification (OOS) results

* Review, instigation and investigation of Customer Complaints including client liaison for these.

* Tracking and close out of CAPA actions

* Tracking and review of Effectiveness checks

* Instigating, review and approval of Change Controls

* Performance of Internal audits from scheduling to close out, including working with Department Heads to agree appropriate actions to address findings.

* Undertaking and coordinating training sessions

* Review and update of SOPs.

* QA Review of Batch Manufacturing and Packaging Records for medical devices and Aseptic Process Simulations.

* Coordination of the New Product Introduction Process for Sterile Manufacturing.

* Hosting Client audits and assisting with Competent Authority and Notified body audits of the Sterile Manufacturing facility. Responding to Client audit report findings having agreed appropriate CAPA with Department Heads.

* Review and approval of label proofs for Sterile Manufacturing and NSCU.

The ideal candidate will have the following experience and qualifications:

* A science-based degree – preferred.

* Some experience of working with aseptically manufactured pharmaceuticals or medical devices.

* Good working knowledge of ISO
13485.

* Good working knowledge of The Medicines Regulations 2012 as amended, The Rules Governing Medicinal Products in the European Union (Eudra Lex Volume
4), and the US Code of Federal Regulations Title 21, relating to pharmaceutical products.

* Competency and experience using Microsoft Office (e.g. Excel, Access & word) and electronic Quality Management Systems (e.g. Q-Pulse, Trackwise).

* Training and experience conducting Audits preferable.

Benefits include:

* Daily travel allowance

* Pension

* Bonus scheme