QA Systems & Compliance Lead - Netherlands
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- The scope of the Centre of Excellence Quality contains: Quality In Process (Integrated QA process teams and Quality Control Labs) for:
- Bacteriological and Viral Inactivated,
- Viral Live,
- Inbound; Raw materials & Warehouse & Media & Support,
- Pharmaceuticals, Packaging & Shipping, Systems & Compliance
- Next to Quality in Process the quality organization consists of several Center of Excellence departments such as an Improvement team, Product Surveillance and a Compliance and Systems team. The vacancy is describing expectations and responsibilities to the role of the QA Systems and Compliance Lead matching the current business need, but is not limited to alternations which might be a better fit to the VOC in the perspective of Continuous Improvement and Development.
- The QA Systems and Compliance Lead is responsible for the cGMP compliance of MMD Animal Health.
- The QA Systems & Compliance Lead reports to the CoE Lead Quality.
- The Team members of QA Systems & Compliance report into the QA Systems & Compliance Lead.
- The primary purpose of the position is to ensure cGMP compliance.
- The QA Systems & Compliance Lead is responsible for hosting the QMS, with specific focus on pillar systems like changes, deviations handling, documentation, regulatory inspections, internal and external auditing.
- The QA Systems and Compliance Lead is connected to Global Compliance and facilitates the Site Quality Council.
- Point of contact for Health Authorities regarding inspections
- Accountable for corrective and preventive compliance actions
- Ensures implementation of the Quality (Compliance) Strategy and Advises by giving direction to the departments
- Ensures compliance in line with regulation and Global Policies
- Responsible for internal audit program, coordination of audits and monitoring follow-up of audits
- Responsible for the preparation, coordination and the follow up of Inspection by Authorities
- Responsible for the Compliance Deployment initiative within the Work-stream Compliance of the site strategy
- Enhances safety culture within the department and ensures safety policies and guidelines are followed in close co-operation with SHE department
- Promotes and displays “Lean” behaviors and “Lean” culture. Coaches and develops his/her team.
- Demonstrates leadership through his/her behaviors in alignment with Merck Leadership Standards and the 12 Inclusive Behaviors.
- Fosters an environment where inclusion, engagement, empowerment and accountability are the "how".
- Assures reports have the capabilities to do their jobs and takes responsibility for growing and developing talent.
Desired skills & experience
- Academic working and thinking level in (Bio)Chemistry/Pharmacy, (Bio)Process Technology or equivalent.
- Preferably a minimum of 5-10 years’- experience in pharmaceutical manufacturing of which 5 years’- experience in quality.
- Demonstrated knowledge of continuous improvement tools and methodology (e.g. Six Sigma).
- Operational management skills and leadership skills to manage change.
- Demonstrated knowledge of cGMP regulations and expectations governing facilities, equipment and procedures for the manufacture of vaccines and pharmaceuticals.
- Knowledge of GMP validation standards.
Analyzing skills/learning ability, communication skills, people-oriented leadership/coaching, task-oriented leadership, focus on results and self-reflection.
- Our company is working to help the world be well.
- Through our medicines, vaccines, biologic therapies and animal health products, we work in more than 140 countries to deliver innovative health solutions to patients and animals.
- 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.
- Our company has a workforce of almost 4500 in the Netherlands at three main sites.
- Our company Animal Health develops and produces vaccines and pharmaceutical specialties for livestock, companion animals and fish.
- We have offices in more than 50 countries, sell our products in over 140 markets and operate in a network of manufacturing sites and research and development facilities around the world.
- We are always seeking innovative talents that focus on constant improvement of our products and the way we work. We’re looking for new colleagues who are entrepreneurs and result driven.
- But not only results matter; how you achieve these results is crucial to be successful within company Animal Health as well.
- Our company Animal Health leads the way in veterinary pharmaceuticals.
- 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.
A good place to work
- Our company is an attractive employer offering interesting opportunities in Research & Development, production and staff departments for an enormous range of disciplines such as biologists, chemists, process engineers, technicians, mechatronic engineers, pharmacists and operators.
- Our company always seeks ‘best-in-class’ employees at all levels.
- We expect a lot from our people and company has a lot to offer them as well.
- Team spirit, entrepreneurship, integrity, leadership and cross-border communication skills are what company values and rewards most.
- If you enjoy being challenged, over and over again, our company will be a good place for you to work.
- We have an excellent fringe benefit program, and we invest heavily in the development of our people.
- Our company gives you plenty of opportunities for individual initiative and responsibility.
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