Sr. QA Specialist

We are looking for a Senior QA Specialist to perform QA support and oversight for equipment, automation and IS validation.

  • This function does NOT develop the technical solutions.
  • ​The QA validation specialist will work under supervision of qualified staff.

Level of independency will vary based on familiarity with the subject (e.g. equipment, automation, etc).
 

Job Description 
  • Perform review and approval of equipment and automation validation documentation, ensuring that Corporate, Site and Regulatory requirements are met.
  • Keeps quality oversight on validation strategy and deliverables for specific projects.
  • Maintain a close contact and familiarity with quality systems.
  • Provide guidance and direction to Quality, Production, Warehouse/Distribution and Supply Chain staff in regards to compliance with quality policies, standards and procedures. 
Profile 
  • Master Degree in Engineering, Pharmaceutical sciences, Process Technology, or equivalent.
  • 10 years of professional experience in GMP environment.
  • 5 years relevant experience in Equipment and Automation Validation, preferably related to secondary packaging.
  • Additional experience with Non Conformances, CAPA’s and Change Control.

Skills and Knowledge:

  • Expanding knowledge of GMP, equipment and automation/IS validation, computer compliance (Annex 11, Part 11).
  • Good attention to detail and excellent writing skills in English language.
  • Effective communication skills at multiple levels and areas (inside and outside of Quality).
  • Good decision making skills and ability to apply risk based approach. Familiar with risk management tools such as FMEA, etc.

Problem Solving:
Logical and linear analytical skills to evaluate and interpret complex situations/problems using multiple sources of information.

Autonomy:

  • Works under minimal direction.
  • Work is guided by operational and project objectives.
  • Manages multiple assignments and processes.
  • Independently determines approach to project.
Contact Information 

Send your application letter and CV, preferably in English, to lemia.nieuwkerk@valesta.com.

For more vacancies go to our website; www.valesta.nl 

Hope to hear you soon!

Application form : Sr. QA Specialist

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