QA Expert Manufacturing

Switzerland, Stein

Randstad Inhouse Services is searching on behalf of Lonza a QA Expert Manufacturing as a Contingent Worker to cover a maternity leave. Starting 1st of July 2020 with a duration of 1 year.

Responsibility

  • Perform batch release for drug product produced in internal and external DP sites

  • Write, review and approve deliverables (e.g. procedures, SOPs, cleaning documents, gap assessments) and related tools (e.g. IT, document systems, training tools, facility validation) to ensure GMP compliance

  • Ensure control that the corresponding elements of the corporate Lonza GMP Quality Manual are appropriately implemented and followed in Sterile Production Stein and at external manufacturing sites

  • Document Review and approval including documents in electronic systems like MES (e.g. batch record)

  • Advice line functions concerning product and process related topics

  • Approve change requests, deviation and CAPAs related to product and process

  • Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory cGMP guidelines, health authority guidance, SOPs, HSE, etc.) Promote and enforce compliance to guidelines

  • Support a culture of high performance and trust. Assure that the required level of knowledge and skills is available and identify competency gaps. Establish and implement training and development plans

Requirements:

  • Academic degree (Master or higher) in Microbiology, Pharmaceutical Sciences or related field
  • 5 years working experience in Quality Assurance in pharmaceutical industries and GMP controlled environment preferable in sterile DP Production
  • Profound knowledge in aseptic manufacturing of chemical and biological drug products
  • Excellent knowledge of written and spoken English
  • Sound knowledge in EU and US GMP regulations relevant for aseptic manufacturing, audit/inspections, qualification/validation, compliance systems
  • Excellent communication skills; Coaches and inspires people to achieve team goals
  • Excellent decision making skills
  • Excellent ability to provide solutions for complex challenges
  • Ability to work independently in a team environment
  • Detail oriented, precise and organized
  • Willingness to learn and carry out new and complex tasks
  • Proactive attitude
Reference: R22296