Associate Quality Assurance Officer

3 weeks ago

Cambridge, United Kingdom Mundipharma Full time

1. 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, supporting company’s inspection readiness and compliance programs.

2. 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 routine 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.
- 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;
- 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 routine deviations and customer complaints related to known failure modes;
- 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.

3. Qualifications:
Experience
- Solid practical experience (+2 years) in GMP roles within the Pharmaceutical and/or Medical Devices Industry

Knowledge and skills
- General understanding of Quality Risk Management;
- Good writing skills and ability to communicate and interact at all levels of the business;
- Application critical thinking when reviewing deviations, change controls and validation documents to ensure the content is sound, logical, and meets regulatory requirements.

Primary Location:
GB Cambridge

Job Posting Date:
2023-04-27

**Job Type**:
Fixed Term Contract (Fixed Term)

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