biotech

Develop and review validation plans, protocols (IQ, OQ, PQ), and reports for computerized systems. Perform risk assessments and impact analysis related to system validation. Ensure compliance with regulatory guidelines such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. Collaborate with IT, Quality

Lead and execute multiple Change Records (Planned events) for the assigned area for creation of new Batch Records and Standard Operation Procedures for Production Support Change Records Assessment and GMP documentation Review. Responsible for providing support to the assigned manufacturing operation

Learn and perform well-defined procedures within a GMP manufacturing setting Perform equipment monitoring & and basic 6S housekeeping Perform basic laboratory tasks (e.g. sampling, pH / conductivity / osmolality measurements etc.) Perform routine sanitization tasks to maintain facility standards Tra