Validation Engineer

Location Groningen, Netherlands
Discipline: Pharmaceutical, Medical Device
Contact name: Ivor Duif

Contact email: i.duif@panda-int.com
Job ref: 10925
Published: 25 days ago

For one of our big pharma clients we are looking for a Validation Engineer! Specifically someone with strong background and experience in Facilities Validation and Clean Drum Validation. This positions is talking to technical services, faciliteis, check pipes and can work both remote and on site.
 

POSITION
Provide support of the product and process development projects of the production process, as also working on the improvement of quality policies and quality systems.


RESPONSIBILITIES
• Zekerstellen van kwaliteitsborging binnen product en procesontwikkelingsprojecten
Uitvoeren en beoordelen van statistische analyses en ondersteunen bij de implementatie van
statistische procesbeheersingtechnieken, steekproefschema’s en andere kwaliteitstechnieken
• Beoordelen en (mede) vaststellen van specificaties voor grond- en hulpstoffen, processen,
halffabrikaten en eindproducten in relatie met interne en externe kwaliteitsnormen
• (Mede) begeleiden van externe (o.a. DEKRA/ FDA) en interne audits (CQA)
• Het opstellen en beoordelen van protocollen en rapporten
• Non-conformity management
• Adviseren, reviewen en (goed)keuren van wijzigingen in producten/processen of systemen,
in lijn met de geldende procedures Goedkeuren van alle QMS gerelateerde procedures en
werkvoorschriften
• Metrics samenstellen en rapporteren
• Input leveren aan het Site Management Review
• Continue verbetering van het focus gebied nav regulatoire ontwikkelingen, trends,
afwijkingen of andere data gedreven inputs.

 


REQUIREMENTS
- Higher vocational education (preferably in the subject of
technology)
- A couple of years of relevant work experience, preferably in the
pharmaceutical or medical-device industry;
- Knowledge of relevant GMP, MDD/MDR, QSR CFR 820, ISO
13485, ISO 14971 regulations;
- Knowledge of quality-assurance systems (QMS);
- Knowledge of relevant work instructions and procedures;
- Knowledge of MS Office;
- Knowledge of validation of technical systems and processes;
- Knowledge of statistics and quality-improvement methods;
- Good communication skills;
- Flexibility and accuracy;
- Ability to work independently and as part of a team;
- Excellent command of the Dutch and English language.

 

DURATION

6 months

 

START DATE
ASAP