Quality Assurance - Auditor I 1 at Charles River Laboratories
5231 Den Bosch, , Netherlands -
Full Time


Start Date

Immediate

Expiry Date

15 Nov, 25

Salary

0.0

Posted On

16 Aug, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Good communication skills

Industry

Pharmaceuticals

Description

Al meer dan 75 jaar werken de medewerkers van Charles River samen om te helpen bij het ontdekken, ontwikkelen en veilig maken van nieuwe geneesmiddelen. Wanneer u bij onze familie komt, heeft u een belangrijke impact op de gezondheid en het welzijn van mensen over de hele wereld. Of uw achtergrond in levenswetenschappen, financiën, IT, verkoop of een ander gebied is, uw vaardigheden spelen een belangrijke rol in het werk dat we uitvoeren. In ruil hiervoor helpen wij u een carrière op te bouwen waar u over gepassioneerd kunt voelen.

JOB SUMMARY

Are you an experienced QA auditor and seeking a challenge elsewhere? Or are you currently working as a laboratory technician or e.g. study director in GLP/GxP laboratory setting and do you want to pursue a different career path?
Is adherence to rules and protocols important to you and do you have a keen eye for quality?
In a quality driven and written standards environment, we look for a communicative, solution-oriented and analytical person who enjoys working together with the different operational departments to maintain the high quality of our work.
At Charles River Laboratories we are currently hiring a:

Responsibilities

ABOUT YOUR ROLE:

As one of the Quality Assurance auditors, you will conduct audits on challenging multi-phase non-clinical studies in an OECD GLP lab environment. Your daily responsibilities are diverse and range from auditing protocols, study data and associated reports to executing process and facility audits to ensure regulatory compliance. In your role as an auditor, you will be liaising with laboratory personnel during on-site study audits and take on an advisory role with respect to the latest requirements of OECD GLP principles and adherence to Charles River’s Standard Operating Procedures.

PRIMARY RESPONSIBILITIES:

  • Perform audits of protocols, in-life critical phases; raw data and final reports to assure compliance with GLP and SOP;
  • Identify, document, and report deviations from regulations, protocol, SOPs, and specifications;
  • Deliver advise to Charles River staff (including management and study directors) on issues relating to GLP compliance;
  • Perform or lead process and facility audits and reviews corresponding regulatory documentation to ensure compliance;
  • Participate in inspections and audits of subcontractors and vendors;
  • Assist in providing basic regulatory training;
  • Harmonize and improve quality processes;
  • Participate in regulatory compliance projects.
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