Opportunities for permanent roles in a range of business sectors

Senior Supply Chain Quality Assurance Officer

Company Description

Mundipharma is a global (ex-US) network of independent associated companies that research, develop and manufacture innovative pharmaceutical medicines and consumer healthcare products. We are an agile and fast-paced company seeking to increase access to health care through programmes and effective partnerships.

We are forward-looking and dedicated to bringing innovative treatments to many of the world’s most challenging conditions and diseases including: Pain Management & Supportive Care, Consumer Health, Anti-Infectives, Biosimilars, CNS, Diabetes, Oncology, Ophthalmology, Respiratory and transplantation immunity.

We make a difference to patient lives by delivering value to healthcare professionals in 120+ countries across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East.

Our guiding principles, centred around Integrity and Patient-Centricity, are at the heart of everything we do. We encourage our people to think differently and our inclusive culture of continuous learning and collaboration make Mundipharma a great place to work.

Accountable for the provision of quality management system (QMS) activities, management and oversight of GxP* third party service providers, and provision of in depth quality advice to our internal and external stakeholders. This will enable Mundipharma to establish, implement, and maintain a system that allows the delivery of products with the quality attributes appropriate to meet the needs of patients, health care professionals, regulatory authorities and other internal and external customers.

Key Responsibilities:

1. Management of medium-high* risk/complexity Third Party providers to ensure GxP compliance, patient safety and reduce risk of market actions (e.g. recall of products) by:

  • Writing new and Updating Technical/Supplier agreements;

  • Ensuring Quality Activities are carried out efficiently and effectively in line with relevant Quality Agreements with associated Mundipharma Supply Chain and manufacturing entities;

  • Conducting effective Quality Review Meetings;

  • Ensuring all regulatory required documentation is in place.

  • Reviewing Periodic Quality Reviews;

  • Reviewing of Stability data;

  • Reviewing of third party Change Control, Deviations, CAPA and Complaints using risk management principles;

  • Reviewing and generating Supply Chain Maps;

  • Participating and working collaboratively with internal and external stakeholders on issue resolution to ensure product quality, compliance and supply;

  • Establishing effective partnership and relationship with third parties;

  • Participating in handover processes when required.

2. To actively carry out medium/high complexity internal Quality Management Systems (QMS) activities including but not limited to:

  • Deviattions

  • Change Control

  • CAPA

  • Complaints

  • Temperature Excursion reports;

  • Technical Agreements;

  • Act as a quality advisor/advocate to ensure tracking and timely closure of internal and external QMS activities utilising Trackwise system;

  • Driving Quality Culture and being accountable for specific areas of the QMS as defined by the Manager of department.

3.To provide support to the team and Manager of the department as and when required, including:

  • Supporting and developing other members of the Quality teams;

  • Generating metrics reports, department reports and KPIs;

  • Proactively driving initiatives to implement new and reviewing and updating existing internal Quality procedures as required;

  • Leading internal projects and contributing to cross-functional projects as required;

  • Carry out any other reasonable tasks as required.

4. Driving and proactively identifying areas for continuous improvement projects within the department, including:

  • Measuring the performance of both third parties and the department to drive continual improvement and reduce risk to the business;

  • Escalation of Significant Quality issues (SQI) to the Manager of the department with proposed actions for issue resolution and risk mitigation;

  • Ensuring compliance with statutory duties, regulation and legislation, including Good Manufacturing and Distribution Practices (GMDP);

  • Understanding the nature, operation and strategy of the organisation and the network of IAC’s and continuously drive for improvement;

  • Driving and supporting the process of continuous improvement with the aim to reduce cost, improve quality and increase efficiency;

  • Committing to personal development and training needs and contribute to other development plans and annual reviews.

5. Actively support and participate in both internal and external inspections including regulatory bodies.

Qualifications

Minimum requirements

Education: Scientific degree or aligned work experience.

Experience - Previous practical experience in Quality roles within the Pharmaceutical Industry (2+ years) or previous practical experience (less than 2 years) in Quality Management Systems within the Pharmaceutical Industry and management of third party suppliers.

Skills and knowledge - 

  •  In depth knowledge of GMDP;

  • Good understanding of a number processes associated with third party management;

  • Demonstrated competency in the application of risk management principles;

  • Ability to solve more complex problems relating to Quality

  • Good knowledge of the manufacturing processes for low risk dosage form types, medicinal and non-medicinal.

Preferred requirements

Certifications - Audit training.

Experience - Previous practical experience (2+ years) in Quality Management Systems within the Pharmaceutical Industry, management of third party suppliers, in depth knowledge of various dosage forms, audit experience.