Title:  Sr Executive QA

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:

1. To ensure GMP compliance to approved procedures / practices as per SOP.
2. 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.
3. Review of Protocol &Reports w.r.t Validation. Stability Study, Hold times Studies.
4. Control and reconciliation of Master / Working Cell Banks and maintenance of relevant documentation. 
5. Review of BPR & Batch release, Analytical data Review and Closure.
6. Handling of Coordinator role for EDMS.
7. Handling of Coordinator role for Track wise.
8. Handling of SAP HANA for PP and Quality Modules of material management, Quality and inventory control through system.
9. To assess Housekeeping activities in all the general areas/GMP associated area in coordination with Admin supervisor/Manager.
10. Arraigning trainings to all GMP departments w.r.t SOPs/Protocols.
11. Issuance, Control & Archival of documents.
12. Any other work assigned by Lead / Head of the Department.

Skills/Competencies:

1. 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.
2. Should have good writing / reading / speaking skills for effective communication, collaboration and for deliverables.
3. 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.