Senior Quality Assurance Officer
Contact length: Permanent
Location: Cambridge
Department: Quality Assurance
Job type: Full Time
Join us and make a difference when it matters most!
At Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees.
The Team
This role will sit in the Quality Assurance team at the Cambridge Science Park, acting as a key point of contact in providing front-line QA support to Bard manufacturing operations. Previous experience in Quality Assurance operations, Pharmaceutical/Medical Device industries and GMP are essential to the role.
This is a double day shift role so will work on a weekly rotational shift basis: Monday - Friday: 6am - 2pm / 1:30pm - 9pm.
Role and Responsibilities
The Senior Quality Assurance Officer will be the first point of call for manufacturing process quality assurance. Other responsibilities of the role include:
- 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, 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
- Contributing to ensure compliance is maintained in all aspects of QA processes in support of the company's inspection readiness and compliance programs
- Leading or supporting internal audits in support of the company self-inspection program
- Leading or supporting external audits of suppliers and third parties if required
- Supporting the business in managing the risk to quality
- Provides coaching and support to the junior members of QA team and acts as a point
What you'll bring
- Scientific degree in Pharmacy, Chemistry, Biology, Engineering or similar, or aligned working experience
- Significant practical experience in QA roles within the Pharmaceutical and/or Medical Devices Industry
- Extensive knowledge and application of GMP and Pharmaceutical regulatory requirements, including solid knowledge of Eudralex Vol. 4 Chapters and Annexes, Orange Guide and key EU Directives, and solid knowledge of the regulatory framework for pharmaceuticals i.e. MIA, GMP cert, MA, types of regulatory variations
- Broad knowledge and experience of various manufacturing process and equipment for various dosage forms
- Previous oral solid dose experience or experience with tablets and capsules would be beneficial
- Solid knowledge of Critical Quality Attributes of solid dose products and what can impact those (e.g. friability, harness, content uniformity, assay, dissolution profile)
- Internal auditing certification and solid experience in GxP auditing
- Experience in supporting external audits by customers and competent authorities as subject matter expert and coordinating backroom support
- Expert technical report writing skills and strong ability to communicate and interact at all levels of the business and externally
- Ability to provide independently front-line support to operations and make decisions on complex failure modes.
What we offer in return
- flexible benefits package
- opportunities for learning & development through our varied programme
- collaborative, inclusive work environment
Diversity and inclusion
Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority. We believe this isn't just the right thing, but also the smart thing to do, as we focus on making a positive difference for our customers and their patients.
About Mundipharma
Mundipharma is a global healthcare company with a presence across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East. Mundipharma is dedicated to bringing innovative treatments to patients in the areas of Pain Management, Infectious Disease and Consumer Healthcare as well as other severe debilitating disease areas. Our guiding principles, centered around Integrity and Patients-Centricity, are at the heart of everything we do.
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Additional Job Description:
Primary Location:
GB Cambridge
Job Posting Date:
2024-07-26
Job Type:
Permanent