• Contract
  • Anywhere
  • Recruiter: Anil Dahiya

Batch Record Reviewer (GMP) – 6185 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 Batch Record Reviewer for a contract role until April 2025 (extension possible) based in the Valais area, Switzerland.

 

Main Responsibilities:

· Review of the executed electronic Batch Records (e.g. cleaning logs, production documentation review, temperature reports, test procedures (HEPT, FIT), Autoclave and Washing machine protocols, used material, calibration records, sample results recorded in LIMS, logbooks, etc.)

·  Review comments added to the executed Batch Records, clarify with the operations team and evaluate with the responsible QA Manager

·  Initiate and support accomplishment of Deviations and investigations for Batch Record review related observations

·  Support the initiation of CRs and TCRs

·  Support preparation of documentation package to enable fast release by QA

 

Qualifications and Experience:

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

·      Degree in Biology, Chemistry, Biotechnology, Life Science or other related field or experience in the field of pharmaceutical industry

·      Previous experience in GDP and GMP regulated pharmaceutical / API industry is an advantage

·      Ability to identify non-compliance and gaps from quality standards

·      Very good communication skills and interaction with all kinds of interfaces within the organization; strong team orientation

·      Structured, focused and well-organized working attitude

·      Open-minded for new ideas and suggestions; solution-oriented

·      Agile, highly motivated and dynamic drive

·      Ability to produce reliable results under stress

·      Knowledge of MES Syncade, DeltaV system (preferably)

·      Fluent in English (German basic knowledge is an advantage)