Senior Quality & Compliance Lead

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This role is a maternity leave cover that needs to be filled urgently, taking CV's for immediate review.

The role provides leadership for regulatory inspections and educates others in the company on all aspects of quality within the company. The key areas of responsibility lie within the areas of Quality Assurance & Compliance, Auditing, Quality Systems and Quality Control.

Key Duties & Responsibilities

Quality Assurance & Compliance

* Ensure that the company maintains compliance with European Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) regulations for Active Pharmaceutical Ingredients (APIs) and Finished Drug Products, the Medical Device Regulations, ISO 13485:2016 for medical devices and any other relevant guidelines related to the business.

* Management Representative for medical devices with notified body.

* Maintain compliance by working closely with the Qualified Person (QP) for medicines and Responsible Person (RP) for GDP as appropriate.

* Responsible for quality improvement projects in the areas of Quality Compliance and Quality Assurance.

* Monitor and ensure Technical Agreements are in place and maintained with all relevant suppliers and service providers for out-sourced activities. Final approval of new and revised Technical Agreements.

* Final quality approval for change controls, deviations, CAPAs, complaints, audits and vendor approvals.

* Final quality approval for commercial release of their products and in-licenced products.

* Have oversight over all aspects of the training system at the company. Ensure that GMP, GDP, medical device training and refresher training is carried out by relevant staff and carry out in-house quality training.

* Ensure that internal and external QA documentation is prepared and completed correctly as per the regulations.

* Reporting of Quality metrics to the Management Team.

* Final approval of customer complaint investigations. Follow up with suppliers / service providers on investigations in conjunction with the Supply Chain Specialist.

* Lead annual Quality Management Review and Product Quality Review meetings.

* Have oversight over:

* Update and maintenance of Quality documents, such as product specifications, and the preparation and update of SOPs.

* Product sample retention system and the document archive system.

* The stability programme ensuring testing is completed and results are reported on time.

Auditing

* Lead preparation and participate in (a) third party audits by health authorities for medicines and (b) notified body for medical devices. Manage the regulatory inspection responses.

* Facilitate inspections of the company by Third Parties e.g. customers.

* Ensure that internal and external audit schedules are prepared and adhered to as planned.

* Ensure the timely review, monitoring and reporting of self-inspections. Final approval of self-inspection reports.

* Perform second party audits and reviews of suppliers and service providers of out-sourced activities. Ensure the review, monitoring and reporting of these external audits.

* Ensure follow-up with auditees with satisfactory and timely closure of audit actions.

Quality Control

* Ensure that the following tasks are completed on time and to a high standard:

* The dispatch of samples to contract laboratories.

* Documentation of testing of products at contract laboratories.

* QA checks on documentation prior to release of products for sale.

* Preparation of Certificates of Analysis.

General

* Provide administrative and/or technical support with respect to preparation, assembly, filing and distribution of information relating to product registrations, compliance and pharmacovigilance.

* Maintain the product technical files.

* Ensure regular Quality Management System updates.

* Ensure that training plans are implemented and training records are maintained.

* Perform other tasks as will be required from time to time.

The Successful Candidate will possess the following:

* 3rd level qualification in a science discipline.

* 8-10 years of experience in the pharmaceutical and/or medical devices industries. Specific experience working in a quality assurance or quality systems role is a requirement for this position.

* Quality Management Systems Auditor / Lead Auditor certified by IRCA or equivalent.

* Strong background in the application of ISO 13485, GMP and GDP standards.

* Experience in regulatory inspections, supplier audits and customer audits.

If this role sounds like one you would be interested in, please apply and we can schedule a call! I can answer any further queries you may have.

Sthree UK is acting as an Employment Agency in relation to this vacancy.