QA Aseptic Process Validation Specialist (5881)

QA Aseptic Process Validation Specialist – 5881 ADA

Our client, a large pharmaceutical organization, is looking for a German speaking Quality Assurance Specialist with experience in Aseptic Process Validation for a 12-month contract (with a high possibility of an extension for another year) in Bern.

Main Responsibilities:

·      Support implementation of the aseptic Isolator Filling Line at their site in Bern

·      Create and update of procedures, risk assessments, concepts.

·      Ensure adherence to global company procedures and standards.

·      Supports creation of the aseptic process validation concept for a new Isolator Filling Line and Lyophilisation process

·      Supports creation of aseptic process validation reports, protocols and procedures

Qualifications and Experience:

·      Relevant working/residency permit or Swiss/EU-Citizenship required.

·      University degree or university of applied sciences degree in natural sciences (e.g., Biology, Chemistry or Pharmacy)

·      Demonstrated strong technical knowledge in the areas of sterility assurance of aseptic cleanroom facilities, their processes and equipment, and personnel to include design and use and life cycle management and cGMP compliance.

·      5 plus years of experience in the pharmaceutical manufacturing industry with direct experience in sterility assurance of aseptic processing

·      Extensive professional experience in aseptic process validation (Media Fill validation), aseptic cleanrooms, process, equipment, consumables, aseptic behaviors, and gowning.

·      Demonstrated experience in quality assurance and regulatory compliance with GxP, FDA, EU and other regulatory agency guidelines.

·      Fluent German and English skills (written and spoken)

·      Background in Sterility Assurance, sterile manufacturing, quality on the floor, aseptic operator training, aseptic process validation (Media Fill) would be highly preferred.