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.
Role and Responsibilities
1. Implement and maintain an effective Quality Management System supporting Global Operations in order to:
2. Enable the manufacture of medicinal products in accordance with current national and international applicable legislation and regulatory expectations, relevant standards and guidelines, and the relevant Manufacturing and Marketing Authorisations.
3. Identify and manage risks to the business through application of Quality Risk Management and effective Change Management.
4. Ensure Quality Management System remains in a State of Control and opportunities for improvement are continuously identified and acted upon.
5. Govern/support the global and local Quality Management Systems by maintaining, tracking, and improving the associated documentation and systems to ensure:
6. Effective processes and procedures are in place in line with Mundipharma Quality Framework and policies, cGMP, and local regulatory requirements.
7. Continuous improvement opportunities are identified and implemented to maintain and advance Mundipharma’s compliance posture and effective and efficient operations.
8. Assess global and local process and product quality performance indicators to monitor whether the pharmaceutical quality system is in a state of control by:
9. Undertaking quality data trend analysis by employing data analytics.
10. Presenting quality data trend analysis at operational and management review forums.
11. Coordinating the writing of local Annual Product Quality Review reports and ensuring appropriate Corrective and/or Preventive Actions are identified as required.
12. Lead the inspection readiness program to maintain and advance Mundipharma’s compliance posture by participating in pre-audit, audit execution, and audit response activities for internal audits in support of the company self-inspection program.
13. Maintain applicable MIA/WDA/API licenses and site master files.
14. Support the hosting of external inspections and customer audits by participating in pre-audit, audit execution, and audit response activities.
15. Support the Quality Operations teams to ensure that electronic Computerised systems records are completed in a timely manner and systems, including upgrades, are implemented in compliance with regulatory requirements.
What you’ll bring
1. Experience in a quality-related role within the Pharmaceutical Industry or related technical industry.
2. Extensive practical experience (5+ years) in Quality Management Systems within the Pharmaceutical Industry and/or Medical Devices.
3. Excellent communication skills (including public presentation and technical report writing skills) and ability to communicate and interact at all levels of the business and externally.
4. Ability to motivate and support the wider Mundipharma team to achieve the goals of the department and the overall business.
What we offer in return
* 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. We are on a journey and will seek to move forward together through education and awareness to build a culture that welcomes and celebrates diversity and uniqueness. We will create a workplace environment where everyone can, every day, bring their authentic selves and is treated with dignity and respect.
About Mundipharma
Mundipharma is a global healthcare company focusing on customers 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, as well as other severe and debilitating disease areas. Their guiding principles, centered around Integrity and Patient-Centricity, are at the heart of everything they do. For more information, visit www.mundipharma.com.
Join our talent pool
If you’re not sure this role is right for you but you’re keen to hear about future opportunities at Mundipharma, join our talent community and be the first to hear about new roles.
#J-18808-Ljbffr