In this role, you will review batch records and collaborate across functions to ensure compliance with GMP and quality standards. You will investigate discrepancies, document findings, and support continuous improvement of batch record processes. 

Start Date: ASAP

Duration: 6 Months

Place of Work: Visp 

Key Responsibilities

  • Review electronic and paper batch records for multiple projects in a timely manner
  • Investigate red flags and comments in batch records (e.g., failed process parameters, material consumption issues, operator notes) using relevant process/data systems and cross-department collaboration
  • Assess and clarify the accuracy of comments and actions on batch records, adding supplementary notes as needed in accordance with GMP, Good Documentation Practices, and ALCOA+ principles
  • Collaborate with BRR team and cross-functional teams to resolve batch record issues and evaluate quality impact statements per GMP and ALCOA+ standards
  • Utilize MES Syncade, DeltaV, Trackwise, SAP, LIMS, DMS, and related systems to investigate batch record issues
  • Perform additional BRR tasks such as Post-Production Lifecycle Document authoring and data cleaning for reports

Candidate Profile

  • Bachelor’s degree or equivalent in life sciences/biotechnology is preferred
  • Prior GMP environment experience is advantageous
  • Experience in production, batch record review, and quality assurance is beneficial
  • Ability to work with minimal supervision and meet deadlines
  • Strong English proficiency; German language skills are a plus (especially reading)

 

 

Job ID 41181187