• 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 Visp, Switzerland.

 

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)

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