Main Responsibilities:
·Review electronic and paper-based batch records for various projects in a timely manner.
·Investigate any 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 collaborations.
·Read and evaluate the correctness of comments added to the batch record and the actions they describe and 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 of MES Syncade, DeltaV, Trackwise, SAP, LIMS, DMS, and other system 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 compliation.
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 would be 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.