Quality Assurance Operations

About our client

Our client is a global healthcare company, with a location in the centre of The Netherlands. Quality Operations (QO) at our clients site has the following sub-functions: Quality Assurance, Quality Systems, Quality IPT, Quality Control and Biological Critical Reagents HUB. The QO Department must ensure adequate quality systems are in place to support the manufacture, packaging, testing, storage, and distribution of products according to their policies, guidelines & procedures and regulatory requirements by appropriate oversight and monitoring.

 

What will you be doing?
As part of the Quality Tracking team, you will join the Quality Operations Department of our client.

 

An overview of your key activities:

  • Responsible as technical reviewer/approver for lab equipment qualification, maintenance and retirement documentation, including calibration and testing protocols of external parties guaranteeing compliance quality policies.
  • Provide technical expertise in investment projects for laboratory equipment, including selection of vendors and their products, and actively participates in the purchasing decision and process.
  • Act as SME and participate in global projects for Data Integrity activities related to computerized and non-computerized lab equipment.
  • Participate in site and global quality improvement projects and acts as a point of contact and SME for lab equipment.
  • Technical approval of purchase and qualification documentation of laboratory equipment in line with current quality directives.
  • Responsible for the archive of approved documentation in MIDAS-CDS
  • Assures that documentation is drafted and reviewed/approved according to client’s guidelines stored in MIDAS-CDS.
  • Participation in cross-functional/global teams.

 

Who are we looking for?
For the position of Quality Assurance Operations, we are looking for a candidate with at least 5 years of relevant experience preferably in pharmaceutical Quality Control and cGMP. Furthermore, a sound knowledge of equipment design and use.

 

We are looking for the following skills & competences:

  • 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)

 

What do we offer?

  • You will be joining the Quality Tracking team, where an experienced consultant will be appointed to you for training and support.
  • An inspiring international client site in a central location in The Netherlands
  • A fulltime position.

 

For more information, please contact Judith Houtman at +31 (0)85 822 82 31 or jhoutman@qualitytracking.nl.

 

Quality Tracking BV
Transistorstraat 7
1322 CJ Almere
The Netherlands
Tel.: +31 85 822 82 31
E-mail: jhoutman@qualitytracking.nl