Currently I am looking for a Qualification Associate Specialist for a big pharmaceutical company near Eindhoven.
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.
Input in Quality Strategy
* 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
* Participates in site audits, regulatory and corporate inspections including support to audit responses as required as SME.
* Provides impact or gives concurrence for MMD-GCM changes, follow up on QNs and CAPAs.
* Participation in cross-functional/global teams.
* Actively pursues information from within the Merck network for best practices.
* Technical expertise, first and second line troubleshooting
* Yellow / Green belt certified
Education, skills & competences and experience
Senior Secondary Professional Educational level (Dutch: MBO/ MLO, HBO/ HLO) preferable in Science.
Skills & competences
* 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)
At least 5 years of relevant experience preferably in pharmaceutical Quality Control and cGMP. Furthermore, a sound knowledge of equipment design and use.
Are you interested in this position and do you want to apply for this opportunity? Please do not hesitate to contact the consultant about this, Niek van Alfen: at 020 522 1588 or at n.vanalfen[at]realstaffing.com.