QA Expert Manufacturing
Randstad Professionals Switzerland
Schweiz, Thurgau, Stein am Rhein
vor 3 Tg.

QA Expert Manufacturing

from : 01.08.2020 till 31.07.2021 with the option for a permanent position

Tasks :

  • 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 : Education

    Education

    Academic degree (Master or higher) in Microbiology, Pharmaceutical Sciences or related field

    Experience

    5 years working experience in Quality Assurance in pharmaceutical industries and GMP controlled environment preferable in sterile DP Production

    Licenses or Certifications

    Knowledge

    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

    Skills

    Excellent communication skills; Coaches and inspires people to achieve team goals

    Excellent decision making skills

    Excellent ability to provide solutions for complex challenges

    Qualities & Attitude

    Ability to work independently in a team environment

    Detail oriented, precise and organized

    Good inter-personal skills

    Energized and open-minded

    Willingness to learn and carry out new and complex tasks

    Proactive attitude

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