Quality Assurance Manager; GES

Job Summary Ensure GMP compliant sources of supply for new and existing AstraZeneca finished products, manufactured and packaged by suppliers under contract with AstraZeneca. Through assessment, review and improvement of Quality Systems at suppliers and within GES. Will be responsible for managing Quality Assurance relationship with contractors.

QA project manage assigned GES projects or programmes to ensure that new and existing suppliers develop in house procedures and subsequently enact and document the technical transfer of AstraZeneca?s manufacturing/ quality testing processes.

Develops and maintains effective business relationships with suppliers to ensure life cycle consistency of delivered products.

Provide GMP compliance support for all areas of strategic supplier manufacturing operations, as appropriate.

Responsibility for preparation and management of the Compliance reporting for the GES QA organization.

Responsibility for management of the GMP Systems program for the GES QA organization, including but not limited to deviation management and documentation system.

As a member of AZ?s Supplier Mgt QA Network, support Supply and Capability (S&C) to maintain an up to date list of strategic suppliers to AZ via the VA&C Database.

Confirm with S&C when GES QA take the Lead Site role (except product release) for supplier selection and establishment.

Carry out initial Quality & Compliance screening and assessment of potential suppliers of projects, as appropriate. Advice and approve the initial choice of supplier, on behalf of their Quality and Compliance capabilities for the project.

Ensure the general and product specific elements of the VA&C database are completed. Undertake and communicate the overall Quality Compliance Assessment Status of suppliers (contractors) of finished and packaged products via the VA&C Database.

Develop, with the QA of launch/ lead sites and suppliers, the QA requirements for supply of materials, in a QA Agreement. Approve the QA Agreement with assigned suppliers on behalf of AZ.

Review any QA related correspondence between AZ and suppliers during establishment and maintenance phases and assist and support, as appropriate.

Maintain the relationship with suppliers (contractors), ensuring the involvement of AZ receiving sites as and when required to:
- Agree audit plan and co-ordinate audits with suppliers. Ensure issued audit reports and follow/up status reports are available in the VA&C Database.
- Organize and participate in monthly/ quarterly/annual activities (as needed) that involve QA review of campaign, supplier QA KPI?s, and overall supplier performance and reporting. Produce an ?Annual Review Report? of supplier performance and circulate to Operations/PR&D sites and GCMG.
- Ensure the supplier has current and relevant QA certification from regulatory authorities, with copies (inc. translations into English) held within the VA&C Database

Advise and support Quality incident investigations at suppliers as appropriate.

Plan, perform and report QA compliance audits against internal and external quality/ compliance standards at third party suppliers, and ensure the delivery of the corrective actions/ improvements opportunities as part of audit follow-up.

Assist with the Integrated Supplier Evaluation Protocol (ISEP) assessments of suppliers.

Effectively communicate information regarding compliance risk to appropriate AZ staff and management to ensure that they are aware of, and fully understand the business, regulatory and technical issues associated with those risks.

Advise and support other GES and AZ Teams on quality matters and process improvements.

Support the review and approval of:
- Planned change requests from suppliers and AZ sites.
- To project manage MCM changes on request.
- Deviation investigations from suppliers.
- Development reports from suppliers.
- Technology Transfer plans, protocols and reports.
- Validation documentation
- Draft CMC documentation data transfer
- Product defect, customer complaints and recalls associated with suppliers.

Support and manage the GES Quality Management System:
- Participate in GES self-inspection programme, reviewing processes and procedures.
- Assist in the production of, or contribution to, departmental and corporate quality documentation (including GES SOPs, Q&C Manual Procedures etc.), this may include authoring, reviewing and approval, as appropriate.
- Propose actions required to achieve, improve and/ or maintain acceptable quality standards and regulatory compliance profile.

To assist preparation of the GES QA Compliance and KPI reports on a monthly basis.

Development of self and others:
- Attend training sessions/ courses as agreed with the line manager.
- Continue to develop knowledge of regulations impacting GES areas of work (e.g. ICH/ FDA Guidelines, etc.).
- Develop and deliver GMP training to others, as appropriate.


Responsibilities

- Holds a minimum of a Bachelor?s Degree in Pure or Applied Science (e.g., Biology, Chemistry, Pharmacy, Chemical Engineering) or other relevant scientific discipline and experience.
- At least 5 years experience in the pharmaceutical / bio-pharmaceutical industry, including having significant experience in Good Manufacturing Practices associated with the manufacture of finished products, both in development and commercial phases.
- The role requires a high level of technical expertise in the areas of QA/GMP compliance, regulatory Compliance, QA/GMP manufacturing and Project Management.