QA Computer System Validation Specialist

仕事内容

Are you passionate about quality assurance, have CSV expertise and are looking for a challenging opportunity in the chemical sector? We have the perfect role for you!

We are actively seeking a QA Computer System Validation Specialist to join our dynamic team and contribute to our commitment to excellence in the manufacture of high quality chemical products.

As CSV Specialist, you will provide technical and regulatory expertise on all subjects relating to computerized, automated and IT system validation in compliance with 21cfr part 11, GAMP and data integrity requirements in our Braine site. Your role will be to define, implement and maintain a strategy for validating and maintaining compliance of computerized system.

Organization

Your Major accountabilities will be:

• Define, implement and maintain a site strategy for the validation of computerized system.
• Write validation protocols and reports linked to computer system validation
• Represent the Braine site in the Global IT compliance group.
• Establish, update GMP documentation (Policy, SOP, MPD, analysis request, etc.).
• Organize and conduct risk analysis related to computer system validation.
• Review, approve and participate in the investigation of deviations and CAPA on computerized and automated system
• Provide support as part of Change control when required computer system expertise.
• Carry out on site audits (GEMBA, etc.).
• Train/raise staff awareness of “good practices”.
• Participate in audits/inspections as SME.
  
  

GMP And Quality

• Develop, implement and manage documents related to quality technics activities in order to comply with the cGMP or other legislation, and with the PolyPeptide Quality System
• Keeping up with the technological innovations and the regulations evolutions
• Ensure a regulatory/industrial watch in terms of computerized system validation.
  
  

Planning

• Plan and prioritize Quality Technics activities in close relationship with the Automation, IT, Production, and Quality Unit in order to minimize the production disturbance, meet the planning objectives as well as the Quality Assurance expectations.
  
  

People management and team spirit

• Participate to a quality mindset within the Quality Unit department
• Motivate, listen to and manage the personnel involved in the qualification activities, maintaining a sound work spirit and discipline
• Implement “empowerment” and “full management” ways of life throughout the organization
• Build a team Spirit throughout the department, allowing sound work relationship
• Manage any relationship problem within the department
  
  

Your Profile

• Master’s Degree in Biology, Biomedical Sciences, Pharmacist, Bioenginneer or similar
• Proven experience (at least 3 years) in computer system validation in the pharmaceutical industry.
• Knowledge of GMPs and other relevant regulations & guidelines
• Analysis skills, organization
• Autonomous and proactive
• Excellent team spirit
• Very good knowledge of French AND English (written and spoken)
  
  

What We Offer

• a full time contract
• an attractive salary
• extra-legal benefits and insurances
• a company car
• a challenging position in an innovative and dynamic work environment with an open culture.