Batch Record Reviewer (GMP) – 6289
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 and Support Specialist for a contract role starting as soon as possible until July 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)
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