QA PROCESS VALIDATION

Contenuto del lavoro

Tech’Firmis a Swiss engineering company with more than 20 years of experience and 300 dedicated engineers.

Our motto: Delivering with happiness!

We offer a friendly environment with trustworthy relationships. Our mission is to give meaning to the activities of everyone in the company.

We are hiring our next QA MANAGER PROCESS VALIDATION (M/W/D)!

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JOB OBJECTIF

The QA will be responsible for manufacturing process validation in the biopharmaceutical plants, including process characterization, validation activities at scale, continued process verification and Product Quality Reviews (PQRs).

MISSION

• Ensure the manufacturing processes: APIs and Intermediates are in a validated state during their whole lifetime according to Lonza procedures, and in compliance with regulatory guidance
• Preparation of comprehensive process specific Validation Master Plans, describing the individual studies required for process validation
• Leading the process validation teams including communication with customers
• Support R&D teams during the process design phase
• Preparation of the validation protocols and reports for the studies performed at manufacturing scale
• Assessment of changes and deviations during manufacturing for their impact on validation

REQUIREMENTS

Education:

• Master Degree in Chemistry or Biotechnology (PhD preferred)

Experience:

• Proficiency in writing scientific reports in English and experience in GMP manufacture preferred

Languages:

• Fluency in English and German required

General skills:

• Excellent communication skills
• Challenges the status quo and looks for opportunities to make improvements in his/her
• area of the business and beyond
• Managing internal and external customer relations professionally and effectively

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WE ARE LOOKING FORWARD TO HEARING FROM YOU !

YOUR TECHFIRM TEAM

www.techfirm.ch

Job Types: Full-time, Permanent