Knowledge of GMP and regulatory guidelines on pharmaceutical manufacturing.
Good communication skills both written and oral.
Time management.
Analytical Problem solving skills.
Continuous improvement skills.
Brainstorming/Ideas generation – tools and techniques.
People management skills.
Experience with performing and hosting inspections is desirable.
Master degree or higher.
Job description of the Section Head Compliance
Department
The Research and Commercialization Quality department in Oss (The Netherlands) holds Quality Assurance oversight of the departments involved in the manufacture and testing of clinical supplies. RCQ’s mission is to achieve local and global quality excellence that ensure patient safety, customer trust and a sustainable innovative product flow. Within the department about 20 skilled professionals are employed in an open and collaborative environment.
Responsibilities
GMP compliance monitoring of Commercialization Operations Oss and the Development Center Oss. Coordinate and supervise:
Internal Audit program
Third Party Auditing
Manufacturer Qualification
Site Documentation (e.g. Site Master File, contact for Manufacturing License / Opiate License)
SOP coordination, review & approval
Hosting customer audits and Health Authority inspections
Technical & Quality Agreement (T&QA) management
To inform the audited departments of developments in regulations and to advise on incorporating these in departmental quality systems.
Profile of the company
MSD
MSD is working to help the world be well. Through our medicines, vaccines, biologic therapies, and consumer and animal products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching programs that donate and deliver our products to the people who need them. MSD is the name of Merck outside the US and Canada. MSD has a workforce of over 6,000 in the Netherlands at five different sites.
MSD is the largest pharmaceutical company in the Netherlands. It has large production facilities for Human Health and Animal Health in Oss, Haarlem and Boxmeer and R&D facilities in Boxmeer and Oss. The MSD Development Center in Oss (DCO) supports MSD’s need for product development activities, particularly for the emerging markets. The DCO is also involved in Product Value Enhancement and it supports MSD’s early phase clinical research in multiple therapeutic areas.
