Specialist QA - IT
Merck Sharp & Dohme Corp
Haarlem, NH, NL
3 dagen geleden

QUA008107

Are you ready for your next challenge in QA and IT?

At MSD Haarlem we have an exciting opportunity for a :

The position

As quality specialist QA IT you will be responsible for the quality aspects of GMP computerized systems and supporting infrastructure used in site facilities, utilities, manufacturing, packaging, labeling, and laboratories to ensure compliance with company policies, procedures and regulatory expectations.

This includes involvement in quality-related activities for computerized systems which are required by the Quality Manual or with potential for impact on product quality, patient safety or data integrity.

You will work closely with stakeholders and SME’s from site operations, quality operations, IT, automation and engineering to provide evidence of quality oversight throughout the computer system lifecycle and facilitate continuous improvement.

Main responsibilities

The Quality Specialist will be responsible for :

  • Collaborating with stakeholders (e.g. System Owners, Process Owners, Data Owner and IT Owner) to assess and select computerized systems to support GMP business processes;
  • to ensure technologies selected meet the high-level business needs; and ensure the initial project tailoring is appropriate for the complexity and risk to accommodate the full scope of work.

  • Providing the independent quality approval of key qualification / validation documentation such as policies, procedures, acceptance criteria, plans, protocols, requirements, reports and computerized system related changes to ensure compliance to company standards and applicable regulations throughout the computerized system lifecycle (including changes / modifications / deviations / variances / compliance investigations).
  • Assuring site / above site system owners have Operating Level Procedures / Plans, approved by Quality, in place and routinely followed to ensure computerized system(s) remain in a validated status (e.
  • g. problem and incident management, change control, periodic review, investigations, backup / restore, System Use and Administrative SOPs, disaster recovery plans, business continuity plans).

  • Reviewing processes and supporting documentary evidence to verify that compliance activities related to computerized systems are in place and effective.
  • Supporting regulatory inspection and audit activities as needed. This includes the review of audit or inspection reports, responding to findings related to IT applications, automated manufacturing equipment, automated lab systems and infrastructure (at local sites) and taking appropriate actions to ensure GMP compliance.
  • Driving resolution of regulatory non-conformance for GMP computerized systems.
  • Monitoring and communicating system health, compliance and other metrics updates to key stakeholders.
  • Promoting GMP awareness and a culture of continuous improvement and facilitating manufacturing process improvements, laboratory operational excellence and validation activities, including latest trends in validation and best practices.
  • Representing QA IT management upon request in local site or system specific meetings regarding computerized systems selection, operation and / or compliance related issues.
  • Contribute in the development and maintenance of training programs in the principles of computerized systems validation and regulatory requirements in validation, maintenance and use of computerized systems.
  • Qualifications

  • Bachelor's degree, preferably in Information Technology, Engineering, Laboratory, Quality or equivalent.
  • Hands-on experience in a regulated pharmaceutical manufacturing and / or laboratory environment (Quality or Compliance role in GMP or Medical Devices environment desired).
  • Hands-on experience and understanding of automated systems supporting pharmaceutical manufacturing, IT infrastructure and / or laboratory operations.
  • Experience in delivering validated IT solutions or an application support role.
  • Good understanding of the current pharmaceutical industry and applicable regulations (FDA / EU / ICH), with emphasis in 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.
  • Familiarity or practical experience in the implementation of quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environment.
  • Limited supervision required in day-to-day activities.
  • Excellent oral and written communication skills in Dutch and English including persuading others and developing cross functional relationships .
  • Analytical problem solving skills, timely decision making, ability to respond to changing priorities.
  • Project management skills combined with a since of urgency and a proven history producing quality deliverables.
  • 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 bonus;
  • 35,5 days of leave;
  • Attractive collective health care insurance package with considerable reduction rates;
  • Solid Pension Plan;
  • MSD Incentive Plan;
  • Travel allowance for commuting;
  • Free in-house sport facilities in Haarlem;
  • Numerous training, coaching and e-learning modules for long term job opportunities and development.
  • Application

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

    About us

    MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.

    Today, we are building a new kind of healthcare company one that is ready to help create a healthier future for all of us.

    Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.

    To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your 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.

    Search Firm Representatives Please Read Carefully :

    MSD is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails.

    All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and / or method without a valid written search agreement in place for this position will be deemed the sole property of MSD.

    No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.#LI-DNI

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