For our Biotech Quality organization in Oss we are currently hiring an :
Quality Systems Officer Lvl1
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Quality Operations (around 120 people) at MSD Biotechnology Operations Oss has the following five sub-functions : Quality Assurance, Quality Systems, Quality IPT, Quality Control and Biological Critical Reagents Hub.
The Quality Department must ensure adequate quality systems are in place to support the manufacture, packaging, testing, storage, and distribution of products according to corporate policies, Guidelines, Procedures and regulatory requirements by appropriate oversight and monitoring.
For more information about MSD Biotech, please watch the MSD Biotech Oss video below.
The Quality Systems Officer L1 is responsible for active contribution to and continuing improvement of MSD Quality Management System and Site Compliance Plan throughout their knowledge and areas of expertise.
The main areas of expertise are in, but not limited to specific task and roles, internal and external inspection and auditing, supplier management including contracts and agreements, quality systems management, document / SOP management and intersite business, GMP Training & Knowledge Management, regulatory affairs and authority liaison function as well as other general specified tasks (e.
g. Site Master File, Manufacturing License).
Such using MSD’s Quality Risk Management tools and in line with MSD’s Lean and Operational Excellence methodology in a safe and compliant matter contribution to patients needs.
Responsible for execution of all internal verification and system / process audit activities which are in line with relevant quality procedures, guidelines and directives to ensure Permanent Inspection Readiness and to monitor the status of GMP level, status and actions steps or other relevant performance indicators.
Responsible for execution of all necessary means with regard to preparations, execution and follow-up on executed inspections at our manufacturing division Biotechnology Operations Oss.
Responsible for all necessary means with regard to Inspection relevant documents (Manufacturing License, GMP Certificate, Site Master File, Authority Accreditations)
Advice / Guidance
Responsible for providing advice / guidance to the functional areas on quality knowledge, procedures, guidelines and directives.
Responsible for supporting Continues Improvement and the supporting of the use MSD’s Quality Risk Management methodologies and tools encourages other to do so.
Responsible for supporting and monitoring decision-making and enable MSD CoE / IPT-members to retain, increase and test (through audits) the required / desired level of expertise.
Leads the Quality Risk Management efforts.
Documentation & Administration
Responsible for monitoring, initiating and ensurance of a compliant level of documents (including data) in a way that it can be used for periodical reviews (e.
Provides day to day support for MSD Biotechnology Operations Oss, raising concerns if needed or directing users to do so.
Responsible for the support of our manufacturing division Biotechnology Operations Oss training initiatives and activitely contribute in the overall and current cGMP knowledge of all personell.
Develop and provide (organize) adequate actual training to personnel in line with the needs of the organization and in order to enhance the site level compliance.
Site related Compliance and Quality Agreement management
Responsible for Compliance and Quality Agreement of Site Services, Site Customers and MSD inter-Site activities.
Responsible for actively contribution to realization of corporate policy on safety, health and environment. Demonstrate personal commitment with respect to working safely, healthy and environmentally friendly.
All functional areas (IPT, CoEs and other MSD departments)
Regulatory Agencies, Inspectors
Other MSD Sites and Global MSD Specialized Groups
Contract Manufacturing Organizations (CMO)
Contract Service Providers (e.g. Archiving, Logistics, Warehousing)
A good place to work
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.
Our company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
For more information on the position please contact Joris-Jan Boons, Assoc. Dir, Quality Systems & Compliance Biotech Oss, by phone : +31 615546168.
If you are interested in this challenging role, you are invited to apply online by uploading your resume and application letter in English or Dutch.