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QA Systems & Compliance Lead Job

Date: May 15, 2017

Location: Boxmeer, NL

Company: MSD

QA Systems & Compliance Lead-QUA005882

Description

The department
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 position
The QA Systems and Compliance Lead is responsible for the cGMP compliance of MMD Animal Health Boxmeer. 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 Boxmeer.

Detailed responsibilities:
• 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 Workstream 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.

Qualifications

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.

Competencies: Analyzing skills/learning ability, communication skills, people-oriented leadership/coaching, task-oriented leadership, focus on results and self-reflection.

About MSD
MSD 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. MSD has a workforce of almost 4500 in the Netherlands at three main sites.

MSD Inventing for Life

For more information, visit our website: msd.nl/career/

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
MSD 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. MSD always seeks ‘best-in-class’ employees at all levels. We expect a lot from our people and MSD has a lot to offer them as well. Team spirit, entrepreneurship, integrity, leadership and cross-border communication skills are what MSD values and rewards most. If you enjoy being challenged, over and over again, MSD 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. MSD gives you plenty of opportunities for individual initiative and responsibility.

Application
If you are interested in this challenging role, you are requested to apply online by uploading your resume and application letter in English.

Job: Quality Operations Job Title:QA Systems & Compliance Lead

Primary Location: EMEA-Netherlands-NB-Boxmeer

Employee Status: Regular

Number of Openings: 1

Company Trade Name:MSD


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