• Contract
  • Valais
  • Recruiter: Anil Dahiya

QA Qualification Specialist – 5469 (ADA)


Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a QA Qualification Specialist based in the VispSwitzerland.


Main Responsibilities:

·      Holds all quality related responsibilities for daily qualification activities on technical facilities i.e. facilities, equipment and technical systems:

       Supports the development, reviews and releases qualification documents according to the validation master plan.

       Master Plan for process plants

       Approves the qualified process plants

       Assesses and approves change requests with regard to their relevance to the qualified state condition and ensures this Supports and approves quality risk analysis (e.g. GMP-FMEA)

       Ensures that deviations are appropriately investigated and addressed in deviation reports processed in deviation reports

       Confirms the qualified status of technical equipment and systems during their life cycle by means of regular life cycle by means of regular inspections of their qualification.


·      Ensures the following QA activities for these specific areas:

       Follows legislation, authority and customer expectations.

       Informs the Group Manager QA Qualification / Validation about relevant developments and trends and develops proposals to improve or expand existing specifications for these qualification areas.

       Actively supports the formulation and further development of qualification strategies and continues to train accordingly

       Supports internal audits in accordance with the internal audit plan in the function of QA expert (SME)

       QA representative (SME) at customer audits and official inspections

       Supports GMP training programs to ensure that staff are trained; and Supports staff development measures within the QA Group.


Qualifications and Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required.
  • Min. 10 years’ experience in Biotech field
  • At least one year as QA Qualification
  •  Knowledge on FAT/SAT/IQ/OQ/PQ and specifically Thermometric Validation
  •   Fluent in English and German (spoken and written), German is mandatory.
  •  Knowledge in Warehouse and shipping processes.
  •   Experience in risk analysis
  • Knowledge of SAP, DMS, TrackWise and KNEAT (KNEAT is a big plus)