*Batch Record Reviewer, GDP, GMP, Pharma, API Industry - 12…

Empresa: Optimus Search
Tipo de empleo: Otros

*Batch Record Reviewer, GDP, GMP, Pharma, API Industry - 12 Months*

Title: Batch Record Reviewer

Rate: Negotiable

Positions Available: 1

Type: Contract (3 months rolling)

A Fantastic new role has just opened up at one of our leading Swiss based clients offering the successful candidate the opportunity to join a hard-working team working on exciting projects in the biotech sector. The proposed start date is ASAP - We need YOU

Responsibilities:

  • Review of the completed batch and/or cleaning protocols, including data such as device printouts, temperature diagrams, test procedures, QC raw data and logbooks, to ensure cGMP-compliant
  • Support batch release by ensuring the completeness of the documentation package
  • Review comments added to the Executed Batch Records, clarify with the operations team and evaluate with the responsible QA Manager
  • Participation in interdepartmental meetings
  • Support the initiation of deviations and investigations for Batch Record review related observations
  • Supporting continuous improvement processes

Requirements:

  • Bachelor in Chemistry, Biotechnology, Life Science or related working experience
  • Previous experience in GDP and GMP regulated pharmaceutical/API industry is an advantage
  • Ability to identify non-compliance and gaps from quality standards
  • Structured, precise and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive
  • Understanding of the applicable cGMP regulations
  • Good knowledge of MS Office, TrackWise and DMS is desirable
  • Very proficient in German and a good command of English