Overview
Batch Record Reviewer – 6681 URA. 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 6 months contract role based in the Valais area, Switzerland.
Responsibilities
* Review electronic and paper-based batch records for various projects in a timely manner.
* Investigate red flags and comments found in the batch record, such as failed process parameters, failed material consumption, and operator comments, by using relevant process and data systems and by cross-department collaboration.
* Read and evaluate the correctness of comments added to the batch record and the actions they describe; provide supplementary comments to clarify if needed in strict adherence to GMP, Good Documentation Practices, and ALCOA+ principles.
* Collaborate with BRR team and cross-departmental teams to resolve batch record issues, such as failed process parameters, and evaluate and provide quality impact statements in strict adherence to GMP, Good Documentation Practices, and ALCOA+ principles.
* Use MES Syncade, DeltaV, Trackwise, SAP, LIMS, DMS, and other systems to investigate issues found in batch records.
* Perform additional tasks of the BRR team such as post-production lifecycle document authoring and cleaning report data completion.
Qualifications and Experience
* Relevant working/residency permit or Swiss/EU-Citizenship required
* Minimum a bachelor’s degree or equivalent in a life science/biotechnological field is a strong plus.
* Previous experience working in a GMP environment is a plus.
* Previous experience in production, batch record review, and quality assurance experience would be highly beneficial.
* Ability to work with minimal oversight fulfilling deliverables within target dates.
* Strong proficiency with English. German is a plus, especially German reading skills.
Details
* Seniority level: Mid-Senior level
* Employment type: Contract
* Job function: Quality Assurance
* Industries: Pharmaceutical Manufacturing, Manufacturing, and Food and Beverage Manufacturing
* Location: Visp, Valais, Switzerland
Note: The original text includes referral prompts and a separate QA Batch Record Reviewer 80-100% (f/m/d) notice which has been removed as unrelated boilerplate content.
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