QMS

Perform/ensure regular facility walkthroughs and raise a work orders if applicable or communicate to respective area supervisor. · Participate/facilitate , external audits / internal audits / self-inspection for Bio-Pharmaceutical Operations to ensure adherence to the implemented systems and compliance with regulatory requirements including Data Integrity assessment. · Track the facility walkthrough checklist and facilitate timely closure of identified action plan. · Participate/track/ensure timely proposal and implementation of appropriate CAPA for audit findings, gaps identified in risk assessments, investigations and implement CAPA to prevent reoccurrence. · Review of executed GMP records within the manufacturing facility (Batch Records, Equipment Usage Logbooks etc.) to ensure adherence to Good Documentation Practice(s), Data Integrity and compliance with approved Standard Operating Procedures. · Perform and support timely preparation, review and approval of GMP documentations for Biologics Operations. o Standard Operating Procedures (EOP, IOP and SOP) o Protocols and Reports o Any other GMP relevant documentation · Participate in batch dispatch activity for technical batches. · Conduct and/or support training on SOPs (including

vernacular language), protocols and on-the-job activities. · Support for timely proposal, appropriate impact assessment and implementation of Change Controls. · Report non-conformities (Deviations) and participate in investigations. · Support for appropriate manufacturing investigations for OOS results and Customer Complaints to identify root cause or most probable root cause and proposal & implementation of appropriate CAPA to prevent reoccurrence. · Support for Risk Management for Biologics Operations covering following elements and ensure proposal and implementation of appropriate risk mitigation actions (CAPA). o Quality and Compliance Risks o Operational Risks o Data Integrity Risks · Gap assessment to be performed for US FDA 483, EU – Non-conformances reports (BMP current practices vs Observation/non conferences) · Review and write response to cross CAPA deployment which are arises internal, external, across the organization. · Refreshment trainings to be performed on GMP/GDP/Data Integrity as when required · Compliance verification Gemba walks shall be performed to BMPs and Warehouse as when required.