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Date: Nov 17, 2017

Location: Boxmeer, NB, NL

Company: MSD

Requisition ID: QUA006383

The QA officer lvl2 is a position within the center of excellence Quality Operations (CoE QO) of MSD AH Boxmeer, the Netherlands. The CoE QO is comprised of several departments designed to oversee manufacturing activities in accordance with current Good Manufacturing Practices (cGMP) and is responsible for ensuring compliance of manufacturing, receipt, storage, testing, processing, packaging, release, holding, labeling and distribution activities during the life cycle of products. The QA officer lvl2 is be positioned within the QA-Integrated Process Team (IPT) department.

The QA officer lvl 2 is responsible for providing advice, support and approval during 1) equipment installation, - qualification and –validation and 2) root cause investigation and corrective and preventive actions. In addition the QA officer lvl 2 reviews and approves standard production documentation and protocols and acts as a subject matter expert for the organization with regard to maintaining GMP compliance within the operational processes.

The open position will be placed within QA-IPT inac, which is responsible for the quality oversight within IPT inac.



Main tasks:



  • Timely review and approval of protocols, reports and deviations in accordance with guidelines and local procedures.

  • Acts as a subject matter expert for GMP compliance during root cause investigations, change control procedures and improvement activities and approves final protocols and reports.

  • Ensures correct administration and documentation of data in accordance with guidelines and local procedures.

  • Advocates safety culture within the organization.

  • Indicates opportunities for improvement and takes part in or leads projects in order to implement changes.

  • Acts as a mentor and coach for QA officer lvl 1

  • Monitors activities concerning compliance and ensures validated status of GMP processes and systems. Ensures that Quality policies, procedures and programs are properly implemented in daily GxP operations and remain up to date.

  • Reviews and approves deviation investigations.

  • Participates in internal and external audits and projects as required.

  • Supports MSD Animal Health training initiatives (i.e. development of training modules, actual training of individuals)
Qualifications

Desired skills & experience



  • Higher education degree (HBO/university or equivalent)

  • At least 5 years of relevant Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with demonstrated experience in investigations, change control, validation and/or audits

  • Extensive knowledge of Good Manufacturing Practice with the ability to interpret and apply in both routine and exceptional situations

  • Knowledge of biological manufacturing processes.
    Competencies:

  • Strong communication skills, both written and oral.

  • Business proficient knowledge of Dutch and English language is mandatory.

  • Self-motivated and the ability to motivate others.

  • Strong organizational skills and ability to manage multi tasks at one time, including the ability to follow assignments through to completion and meet timelines (commitment to task, attention to detail).

  • Strong safety awareness. Able to identify potential safety risks and take responsibility in addressing the risks.

  • Demonstrated ability to work as both a team player and independently.

  • Skill in evaluating operations according to company and regulatory guidelines (policies, processes, procedures).

  • Pragmatism – Ability to make decisions in a highly complex environment that balance business needs, quality and compliance risk and other constrains.

  • Ability to manage and distribute workloads.

  • Ability to provide direction and establish goals for individual staff members and work groups (planning/prioritizing/goal setting).

  • Drive for improvement – out of the box thinker, able to manage ambiguity. Demonstrated ability to push boundaries and able to challenge status quo to uncover fresh innovation.

  • Resilience – ability to manage diversity and conflicting viewpoints at senior levels.

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 Inventing for Life

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

MSD’s Animal Health (MAH) division works to improve the health of animals around the world through collaborative partnerships and a deep sense of responsibility towards our customers, consumers, animals, society, and our planet. This team of energetic, independent thinkers offers one of the industry’s most innovative portfolios of products, services, and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species both domestically and internationally.



Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.

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.

Information
For information about this vacancy please contact Judith Tiggelers (QAIPT Lead inac, Boxmeer), phone +31 (0) 485 585 542

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
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Employee Status: Regular
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Company Trade Name: MSD


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