EBR (Electronic batch record) Reviewer QA / OPs
at KPC International
4 days ago
Electronic Batch Reviewer 3–6-month contract Immediate start.
Visp, Valais, Switzerland (On-site)
KPC International - Excellence from Concept to Completion
KPC International began operations in 2001, our team of Engineers and Scientists have helped our clients achieve project success all over the world within the pharmaceutical and biopharmaceutical space.
We specialise in Plant Facility Start-Up from Strategy and Planning to Execution, through to Operational Readiness. We are proud to support our clients in delivering their life changing products to patients.
Primary responsibility for all batch release activities to ensure that products are manufactured and released in accordance with regulatory requirements and the principles and guidelines of current Good Manufacturing Practices and Good Documentation Practices. The Batch Record Review Specialist will provide technical quality leadership and support for the manufacturing department.
Main tasks:
• .Support new product launches by assisting with the creating of a release process.
• Report quality system metrics relating to product release activities as required
• Review executed electronic Batch Records, including cleaning logs, production documentation, temperature reports and test procedures
• Clarify comments and discrepancies in Batch Records with the operations team and evaluate them with the QA Manager
• Initiate and support the investigation of deviations and observations related to Batch Record reviews
• Assist in the initiation of Change Requests (CRs) and Temporary Change Requests (TCRs)
• Ensure all appropriate batch related documents are available, and all documentation issues including queries, deviations, change controls, out of specification investigations and CAPAs are closed to enable release of products in a timely manner. Communicates with cross functional team to align on product release timelines and resolve batch record issues
• Prepare documentation packages to support fast and efficient product release by QA
Main qualifications
Bachelor’s degree with a minimum of 2 years’ experience in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field.)
• Previous experience in GDP and GMP regulated pharmaceutical or API industry is advantageous
• Must have used an electronic batch record system.
• Ability to identify non-compliance and gaps from quality standards
• Strong communication skills and ability to interact with various teams across the organization
• A structured, focused, and organized work approach
• Open-mindedness and a solution-oriented attitude
• Agile and highly motivated with the ability to produce reliable results under pressure
• Knowledge of MES Syncade and DeltaV system is preferred
• Fluent in English; basic knowledge of German is an advantage
KPC -International offers an inclusive environment where you can broaden your experience, perspective and skills to help make an impact on the lives of others.
KPC – International is an Equal Opportunity Employer.
Job Functions
* Manufacturing, Quality Assurance, and Production
#J-18808-Ljbffr