vacature kwaliteit

Computer System Validation Engineer

  • Tijdelijk dienstverband
  • Oss, The Netherlands
  • Referentienummer: DT/19-034-DD

Derks & Derks

A temporary assignment for at least 6 months at a large pharmaceutical company (Oss, The Netherlands)

Offer
  • a challenging job within a large pharmaceutical company
  • a temporary assignment till at least the end of this year
  • contract of Derks & Derks Secondment & Interim

 

Organisation

Our client is a world leader in the healthcare industry. Through their medicines, vaccines, biological therapies, and support services they offer health solutions for people and animals in more than 140 countries. They also demonstrate their commitment to an increasing access to healthcare through far-reaching programs that donate and deliver their products to the people who need them. The organisation has three main locations with approximately 4,500 employees. This position is located in Oss.

 

Position

As a Computer System Validation Engineer you are responsible for the quality aspects of GMP computerized systems and supporting infrastructure. These are 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.

You will review processes and support documentary evidence to verify that compliance activities related to computerized systems are in place and effective. Besides this you will support 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.

You will also promote 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. Besides this you will 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.

 

Profile
  • Bachelor’s degree, preferably Information Technology, Engineering or equivalent
  • 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
  • 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.

 

Response

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/19-034-DD, to Djamila Hagemans: info@derksenderks.nl.

For further information, please call Djamila Hagemans at number +31 (0)33 472 80 87.

 

An individual assessment may be part of the selection procedure.

 

Our Client has chosen Derks & Derks Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

 

Apply directly

If this is not quite the position you are seeking, please check https://www.derksenderks.nl/vacatures for other interesting jobs!

 

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