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Qualification Specialist

Oss, Netherlands

Job Description

We are looking for candidates with excellent interpersonal and communication skills, a flawless quality mindset and able to convert this mindset into practice. You bring strong leadership skills to bring others on the same page and the ability to act as the right hand of the QA & Compliance Lead.

We have an exciting new job opportunity at our location in Oss and are looking to hire a Quality Assurance/Qualification Specialist

Welcome in our team

Our Biotech Operations organization in Oss (around 550 employees) is accountable for the commercial manufacturing of drug substances for our biologics-based medicines, including the area of immuno-oncology. The manufacturing is supported by lab scale manufacturing and labs with extensive testing capabilities. Quality Operations Biotech (around 120 employees) ensures that our Manufacturing Division Oss manufactures, tests and releases Biological Drug Substances and Bulk Drug Products in accordance with applicable local and international regulations. To this end, the various Quality departments (Quality Compliance, Quality IPT and Quality Control) actively collaborate and set standards for all other Integrated Process Teams (IPT’s) and CoE’s (Center of Excellences) of our Manufacturing Division Oss as well as regularly interact with other Manufacturing Division sites. Within Quality Compliance, the Quality Assurance & Compliance team (10 employees) ensures compliance of our infrastructure with regulatory legislation and our Quality Management System (QMS).

Purpose of the role

Under the direction of the QA-Compliance Lead, you are responsible for quality oversight during the life cycle of computerized systems, equipment, facilities and utilities, among other systems, and maintaining the qualified status of the quality systems associated with production process and lab systems. You strongly collaborate with our Global partners from DDQ (Digital and Data Quality) for computerized system and automated system validation (CSV) supporting pharmaceutical manufacturing, IT infrastructure and/or laboratory operations.

Tasks and responsibilities are, but not limited to

  • Act as a specialist for quality oversight during the life cycle of computerized systems, equipment, facilities and utilities, among other systems, and maintaining the qualified status of the quality systems associated with production process and lab systems.
  • Act as the specialist within QMS section of QA-Compliance department. follow the assigned QMS topics, driving standardization, improvement and knowledge transfer of the QMS topic.
  • Strongly collaborate with Global DDQ for computerized system and automated system validation supporting pharmaceutical manufacturing, IT infrastructure and/or laboratory operations
  • Ensures site compliance with Deviation Management MMD QMS.
  • Supporting and monitoring decision-making and enable CoE/IPT-members to retain and increase the required/desired level of expertise on Quality and cGMP Compliance topics.
  • Providing advice/guidance to the functional areas on quality knowledge, procedures, guidelines and directives.
  • Supporting continuous improvement initiatives related to QA-Compliance Department.
  • Providing day-to-day support for our organization, raising concerns if needed or directing users to do so. Partner with relevant internal and global groups.
  • Active contribution to realization of corporate policy on safety, health and environment. Demonstrate personal commitment with respect to working safely, healthy and environmentally friendly.

Your profile

  • Bachelor's degree in science (HLO Hoger Laboratorium Onderwijs);
  • 5+ years of relevant experience in a pharmaceutical manufacturing organization.
  • Extensive knowledge of cGMP, Quality and Compliance guidelines, Quality Management Systems and Operational Quality principles.
  • Good understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis on Data Integrity, 21 CFR Part 11, 210, 211 and 820 and local regulatory expectations.
  • Must demonstrate working knowledge of the principles, theories and concepts of computerized system validation / compliance.
  • Strong communication skills, oral and written in Dutch and English.
  • Possibility to travel to Oss site at least 3 days a week, preferably more.

What we offer

We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.

  • Competitive salary and a 3% year-end allowance.
  • 35,5 days of leave.
  • Attractive collective health care insurance package with considerable reduction rates.
  • Solid Pension Plan.
  • Annual bonus based on own and company performance.
  • Travel allowance for commuting.
  • Numerous training, coaching and e-learning modules for long term job opportunities and development.
  • Flexible working arrangements.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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Requisition ID: R277332

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