Quality Assurance Officer

2 months ago

Cambridge, United Kingdom Mundipharma Full time

Job Purpose

Provides front-line QA support to Bard operations, including as part of investigations into Deviations and/or Customer Complaints and in design and implementation of appropriate corrective / preventive actions and associated effectiveness checks, executing and supporting Supplier Quality Assurance activities, including maintaining qualification and compliance status of raw material and packaging suppliers and associated vendor assurance requirements, supporting company’s inspection readiness and compliance programs, providing QA support to projects and change controls.

Key Responsibilities
- Providing front-line QA support to Bard operations by:

- proactively carrying out walkabouts within the operational areas, ensuring continuous compliance of Bard operations to GMP and company requirements and providing QA guidance as required;
- advising in the event of deviations, including with regards to containment actions and product disposition, liaising with senior members of the QA team and/or QA Manager and Qualified Person, and overseeing and reviewing investigations and the design and implementation of appropriate corrective / preventive actions and associated effectiveness checks;
- leading/facilitating Quality investigations for the identification of root causes and continuous improvements as a result of Deviations and/or Customer Complaints in conjunction with the relevant functional areas, communicating and monitoring the implementation of appropriate corrective / preventive actions;
- identifying and implementing continuous improvement opportunities to maintain and advance Bard’s compliance posture and effective and efficient operations, as well as continuously enhancing Quality culture across the organisation.
- Executing and supporting Supplier Quality Assurance activities, including:

- maintaining qualification and compliance status of raw material and packaging suppliers;
- maintaining raw material and packaging suppliers risk rating and associated material sampling plans;
- managing raw material and packaging suppliers and Third-Party service providers, in accordance with current legislation, relevant standards and guidelines, including by updating/writing Supplier Quality Agreements, conducting effective Quality Review Meetings when necessary, reviewing Suppliers and Third-Party Change Control, Deviations, CAPA and Complaints;
- creating and maintaining Supply Chain Maps for Bard manufactured products;
- raising complaints with Bard suppliers and approving supplier complaint investigations and associated CAPA plans.
- Contributing to ensure compliance is maintained in all aspects of QA processes in support of the company’s inspection readiness and compliance programs by:

- delivering on-time personal Quality System commitments (including Change Control actions, CAPA, training, document periodic reviews);
- supporting internal and external audits ensuring all relevant documentation is ‘inspection ready’ and timely available;
- participating if required in internal audits in support of the company self-inspection program;
- participating if required in external audits of suppliers and third parties;
- collecting, evaluating and communicating key quality metrics, including in support of standard process such as Annual Product Quality Review and Management Review.
- Supporting the business in managing the risk to quality by:

- contributing as part of a team to complex risk assessments (e.g. FMEA) and the identification of risk control measures as appropriate;
- writing risk assessments in support of the disposition of deviations and customer complaints;
- contributing as part of a team to the definition of control strategy for new equipment and/or processes, in close collaboration with the Production and Validation teams;
- providing support and advise in projects / change controls as required.

Education
- Minimum required - Scientific degree in Pharmacy, Chemistry, Biology, Engineering or similar, or aligned working experience
- Preferred - Scientific degree in Pharmacy, Chemistry, Biology, Engineering, or similar

Experience
- Minimum required - Solid practical experience (+2 years) in QA roles within the Pharmaceutical and/or Medical Devices Industry
- Preferred - Significant practical experience (+4 years) in QA roles within the Pharmaceutical and/or Medical Devices Industry

Knowledge and Skills
- Good knowledge and experience of Quality Risk Management, including in risk assessment tools e.g. FMEA, HACCP;
- Knowledge and experience of various manufacturing process and equipment for various dosage forms;
- Knowledge of water generation process and filtered air supply (various treatment steps and associated controls);
- General understanding of Critical Quality Attributes of solid dose products and what can impact those (e.g. friability, harness, content uniformity, assay, dissolution profile);
- Previous experience in supporting external audits by customers and compete

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