Laboratory Manager
Merck Sharp & Dohme Corp.
Oss, NB, Netherlands
32 dagen geleden

Description

For our Pharm Ops Quality Operations organization in Oss we are currently hiring a :

About MSD

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.

The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-

year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

MSD Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide.

Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

MSD. Inventing for life. For more information, visit our website : www.werkenbijmsd.nl

The organization

Quality Operations Pharm Ops (around 250 people) is responsible for ensuring that our Manufacturing Division Oss manufactures, tests and releases Drug Products in accordance to applicable local and international regulations.

To this end the various Quality departments actively collaborate and set standards for all other Integrated Process Teams (IPTs) and CoEs (Center of Excellences) of our Manufacturing Division Oss as well as regularly interact with other Manufacturing Division sites.

The Position

Reporting to the Director Quality Control QC-Analytical Chemistry, the Laboratory Manager (internally : Lab Coach) will manage a laboratory team (around 8-

15 people) with the following responsibilities : assure GMP compliant and timely analysis of release, stability batches and special analytical requests.

Other tasks / responsibilities :

  • Providing general management and guidance to compliance with company policies, standards, procedures, cGMP’s, GLP’s, and regulations;
  • Maintaining up to date analytical procedures used by the company;
  • Enforcing safety procedures in the laboratory, concerning the analysts and / or other employees who visit the laboratory area;
  • Assuring training is provided to the laboratory employees on regulations under the cGMPs requirements and also responsible for the on-
  • the-job training of the team;
  • Planning, managing and providing quality expertise to cross-functional investigations;
  • Reviewing and approving investigations associated with all areas of responsibility and providing support on data evaluation, investigation and in exercising sound decision making;
  • Managing and attending assigned area regulatory inspections;
  • Supporting management to provide responses to audit observations and findings;
  • Investigating most probable cause for products trends, complaints and deviations to recommend sound corrective and preventive measures to avoid recurrence;
  • Managing and monitoring assigned area departmental budget.
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