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Senior Quality Assurance Manager
2 months ago
We are seeking a highly skilled and experienced Senior Quality Assurance Officer to join our Quality Assurance team at Mundipharma. As a key member of our team, you will be responsible for providing front-line QA support to our manufacturing operations and ensuring compliance with GMP and company requirements.
Key Responsibilities- Proactively conduct walkabouts within operational areas to ensure continuous compliance with GMP and company requirements, providing QA guidance as needed.
- Advise on deviations, including containment actions and product disposition, and oversee and review investigations and the design and implementation of corrective/preventive actions and associated effectiveness checks.
- Lead/facilitate quality investigations for the identification of root causes and continuous improvements as a result of deviations and/or customer complaints, communicating and monitoring the implementation of appropriate corrective/preventive actions.
- Contribute to ensuring compliance is maintained in all aspects of QA processes in support of the company's inspection readiness and compliance programs.
- Lead or support internal audits in support of the company self-inspection program.
- Lead or support external audits of suppliers and third parties as required.
- Support the business in managing risk to quality.
- Provide coaching and support to junior members of the QA team and act as a point of contact.
- 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.
- Broad knowledge and experience of various manufacturing processes 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, hardness, 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.
- A flexible benefits package.
- Opportunities for learning and development through our varied program.
- A collaborative, inclusive work environment.
Mundipharma is a global healthcare company with a presence across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East. We are 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.
