Qualification Associate Specialist

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  • Offer € 50,000 - € 60,000
  • Job category IT
  • Contract Fulltime
  • Reference number 9134300
  • Location Oss
  • Contract type Secondment via YER
  • Industry Medical & Health

About this vacancy

Quality Operations (QO) at MSD Biotechnology operations Oss has the following sub-functions: Quality Assurance, Quality Systems, Quality IPT, Quality Control and Biological Critical Reagents HUB. The QO Department must ensures adequate quality systems are in place to support the manufacture, packaging, testing, storage, and distribution of MMD products according to MMD Policies, Guidelines & Procedures and regulatory requirements by appropriate oversight and monitoring.

Job Purpose:

Responsible as technical reviewer/approver for lab equipment qualification, maintenance and retirement documentation, including calibration and testing protocols of external parties guaranteeing compliance MMD quality policies. Provides technical expertise in investment projects for laboratory equipment. Responsible for establishing the annual maintenance program. Acts as SME and participates in global projects for Data Integrity activities related to computerized and non-computerized lab equipment.

Job description

  • Responsible as technical reviewer/approver for lab equipment qualification, maintenance and retirement documentation, including calibration and testing protocols of external parties guaranteeing compliance MMD quality policies
  • Provides technical expertise in investment projects for laboratory equipment, including selection of vendors and their products, and actively participates in the purchasing decision and process
  • Acts as SME and participates in global projects for Data Integrity activities related to computerized and non-computerized lab equipment
  • Maintain the QCB qualification planning
  • Responsible for providing technical expertise and performing review tasks related to MMD-GCM changes and ECM changes concerning lab equipment
  • Responsible for establishing the annual maintenance program in collaboration with internal and external parties, providing the technical information for contractual terms as needed
  • Participates in site and global quality improvement projects and acts as a point of contact and SME for lab equipment
  • Responsible for initiating MMD-GCM changes and ECM changes related to lab equipment
  • Supports lab investigations process as needed
  • Acts as Person in Charge (PiC), responsible for archive of equipment related documentation
  • Technical approval of purchase and qualification documentation of laboratory equipment in line with current quality directives
  • Acts as quality expert for laboratory instrument maintenance and automation
  • Responsible for the archive of approved documentation in MIDAS-CDS
  • Assures that documentation is drafted and reviewed/approved according to MSD guidelines stored in MIDAS-CDS

Company

In 1923, Saal van Zwanenberg started Organon, where at that time pancreatic porcine insulin was purified. It was the start of over 90 years of innovative pharmaceutical production in Oss. Approximately 1,500 colleagues currently work on the production and development of medicines at two locations.

Quality Operations (QO) at MSD Biotechnology operations Oss has the following sub-functions: Quality Assurance, Quality Systems, Quality IPT, Quality Control and Biological Critical Reagents HUB. The QO Department must ensures adequate quality systems are in place to support the manufacture, packaging, testing, storage, and distribution of MMD products according to MMD Policies, Guidelines & Procedures and regulatory requirements by appropriate oversight and monitoring.

Provides day to day support for Biotech Operations, raising concerns if needed or directing users to do so. In co-operation with functional areas and in line with quality procedures and guidelines, support the handling of deviations, including implementation of CAPA’s. Partner with internal and global groups for technical issues resolution related to investigations or system issues.

Agreements

We welcome you to a challenging, innovative environment with great opportunities for you to explore. YER is preferred supplier. You will be employed by YER and seconded to MSD.

Our benefits are very competitive and designed around your preferences:

  • A competitive salary depending on experience
  • Extensive set of tools to drive your career, such as a personal development budget, training and coaching
  • Healthy work-life balance

Candidate profile

  • Knowledge and experience with quality and compliance guidelines, cGMPs
  • Knowledge of industry guidance and respective regulations of Equipment Qualification and Maintenance, Validation, Quality Control, Quality (Management) Systems, Documentation, Change Controls
  • Technical knowledge in testing techniques and lab equipment
  • Technical Writing, Failure Mode & Effect Analysis (FMEA), and Lean Six Sigma.
  • Effective project management planning skills and ability to communicate on prioritization and bring others on the same page
  • Computer literacy knowledge
  • Ability to work under minimum supervision.
  • Strong focus on clients and end-user
  • Hands on mentality
  • Good communication skills and being pro-active and flexible
  • Team work oriented
  • Flawless Integrity Mindset (Data Integrity)
  • Excellent interpersonal and communication skills, oral and written (Dutch and English)
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