Leading the department and involved in various QA functions as listed below: Review, Approve and ensure the objective of Quality Management System & compliance. • To ensure resolution of deviations, incidents, change control are established and implemented • Review and assessment of vendors, audits & execute quality agreements• Review & Approval of Master documents like SOPs, Method Validation Protocols & Reports, Process Validation Protocols & Reports, Batch Manufacturing Records, SMF, BOM, Sampling Plan, Stability Summary Reports, Specifications, MOA, STPs etc.• Collate, evaluate data and identify areas for improvements including GMP & GLP, ensure the compliance of training as per training matrix• Review and approval of Technology Transfer Documents, Method Transfer Documents, Data compilations for internal and regulatory requirements, Equipment qualification• Compliance ICH Q8 guideline in product development report, Supporting Regulatory Affairs in submissions and responding to ANDA queries• Assisting Departmental Head in various Client Audits, Handling of customer and regulatory audit documentation• Attending T-cons with Client’s for project updates and to resolve the client’s product related queries.• Coordinating with cross functioning departments to smoothen the work flow and to achieve milestones with accuracy and as per predetermined schedule• Achievements:-• Promoted thrice, from Research Officer to Sr. Research Officer to Assistant Manager to Deputy Manager• Leading the Department and handling the team of four Technical Personnel & Two documentation personnel

• Review and Issuance of Standard Operating Procedures (SOP)and Specifications, BMR, BPR.• Review of QC reports• Working with QM module of SAP system• Preparation of Annual Product Review• Assisting departmental head in internal quality audits, MHRA, USFDA audit• Other documentation work