Job Description

Main purpose of the Job:Responsible for day to day Quality operations which includes Production & Warehouse areas, Admin / HR GxP associated areas shop floor compliance and handling of QMS elements pertinent to entire Bulk manufacturing, QC & Warehouse.GMP rounds as part of periodic and routine facility maintenance / assurance on EM / Water monitoring, mfg. assurance in order to ensure the product SISPQ (Safety, Identity, Strength, Purity & Quality) while batch review / release through a proper tracking mechanism in place.Review of process technical / regulatory documents, coordinating with SMEs and assisting to the HOD.Job Responsibilities: * To ensure GMP compliance to approved procedures / practices as per SOP.

• To Handle Out of Specification (OOS), Deviation, Out of Trend (OOT), Laboratory Event, Change Control, Corrective Action and Preventive Action (CAPA) with assurance of appropriate Action Plan Through Trackwise System.
• Review of Protocol &Reports w.r.t Validation. Stability Study, Hold times Studies.
• Control and reconciliation of Master / Working Cell Banks and maintenance of relevant documentation.
• Review of BPR & Batch release, Analytical data Review and Closure.
• Handling of Coordinator role for EDMS.
• Handling of Coordinator role for Track wise.
• Handling of SAP HANA for PP and Quality Modules of material management, Quality and inventory control through system.
• To assess Housekeeping activities in all the general areas/GMP associated area in coordination with Admin supervisor/Manager.
• Arraigning trainings to all GMP departments w.r.t SOPs/Protocols.
• Issuance, Control & Archival of documents.
• Any other work assigned by Lead / Head of the Department.

Skills/Competencies: * The candidate should have good knowledge on Fermentation and Protein purification process of Biological products and basics of Molecular biology i.e. Clone/Host Org. development/screening, Master cell Banks etc.

• Should have good writing / reading / speaking skills for effective communication, collaboration and for deliverables.
• Computer literacy, Computer system Validation (QC lab and Process Control systems) concepts and automation systems handling including any Quality/statutory certifications of ISO/QMS is added advantage.

Sun Pharmaceutical Industries