1) Experience in intermediates and API manufacturing activities – including processes involving fermentation, chemical synthesis and potent products.
2) Experience in handling QA activities of Manufacturing and Quality department operations
3) Establishing SOP’s and protocols to maintain/upgrade compliance levels in all the QMS, Validations and qualifications in line with the latest guidelines.
4) Development, establishment, and review of policies towards Data integrity management.
5) Responsible to ensure compliance of activities across different sites of API towards – warehouse, manufacturing, QC, and supply chain operations.
6) GMP compliance review across the entire quality management system documentation for all API sites – including Change management, investigations, complaints, Returns, Recall and CAPA.
7) Preparing and reviewing the sites for regulatory inspections
8) Regulatory audits CAPA management and establishment of compliance for historically cited observations through SOP governance and internal audits
9) Systems establishment for Development, qualification and validation of equipment’s, products, processes, cleaning, utilities. Comprehensive compliance review of various documents at Site.
10) Computerized system and software qualification and validations, electronic data management, Develop Computerized system Audit trail approach and reviews
11) Design and commissioning of manufacturing and lab Facility including risk-based qualification
12) Temperature mapping in facilities and equipment’s
13) Risk assessment and contamination control management
14) Vendor qualifications including site audits
15) Implement CAPA programs across multiple sites on a risk-based approach
16) Training in cGMP operations and SOP’s
17) Facing regulatory and customer audits.
18) Development, Qualification and operation of QMS digital solutions
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