Qualification / Validation Compliance Engineer (Pharma)

☞ Consultys Switzerland

View: 120

Update day: 24-04-2024

Location: Zürich Zürich ZH

Category: Pharmaceutical / Chemical / Biotech

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About Us

Consultys Group is a 100% specialist LifeScience consulting firm. With more than 490 experts working in France, Belgium, Germany and Switzerland on major engineering, R&D and compliance projects for the world’s leading pharmaceutical, medical device and biotech companies.

Consultys links operational compliance, quality, processes, R&D, regulatory, own solutions and technology in ways that master complex business challenges to help its LifeScience clients exploit their existing strengths and develop new capabilities by combining its experience and innovative thinking across in the regulated environment.


Role & Responsibilities

The Qualification and Validation Compliance Engineer will support our Pharmaceutical client and conduct validation studies, technology transfer activities, process characterization studies and gauge R&R studies within the Manufacturing Process. This position will also provide guidance on the equipment/process validation requirements and design control activities for new product development projects.

  • Support/conduct FAT/SAT and then IQ/OQ/PQ validation studies of equipment and processes, utilities and software validations

  • Advise project teams, develop/review and approve validation protocols and final reports

  • Manage Change Control on material specifications and documentation, develop and validate test method validation

  • Support of continuous improvement on process, and on Qualification and Validations project

  • Maintain equipment to support GMP manufacturing ensuring all equipment complies with Standard Operating Procedures and Policies

  • Participate in project planning, scheduling, and tracking

  • Develop and implement procedures to comply with corporate and industry standards

  • Provide internal and external trainings


Requirements

  • University degree in Engineering, Chemistry or another relevant discipline

  • At least 2-3 years of experience in Qualification and Validation activities and/or projects

  • Applied knowledge of SwissMedic and FDA and international Pharmaceutical regulations

  • Applied technical understanding of manufacturing equipment; processes specific to Pharmaceutical manufacturing preferred

  • Applied Knowledge of creation and verification of qualification equipment plans (FAT/SAT/DQ/IQ/OQ/PQ)

  • Analytical and structured working style; strong attention to detail

  • Ability to effectively work as part of a multidisciplinary, international team

  • Hands-on personality, with flexibility and dedication to maximize our client`s value

  • Fluency in English is required, German, French or Italian would be a plus

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Deadline: 08-06-2024

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