Quality Engineer

As a Quality Engineer your are 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. 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.

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 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.                                • Participates 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 guidelines stored in MIDAS-CDS.                                                                                                 • Participation in cross-functional/global teams.

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)

At least 5 years of relevant experience preferably in pharmaceutical Quality Control and cGMP. Furthermore, a sound knowledge of equipment design and use.

Interesse?

Mail dan je CV, zodat wij zo spoedig mogelijk contact met je op kunnen nemen.

Geef een reactie

Het e-mailadres wordt niet gepubliceerd. Vereiste velden zijn gemarkeerd met *