Dharmendra Sharma

About Dharmendra Sharma

Experienced Manager Quality Technical cell with a demonstrated history of working in the…

Experience

1. Manager-cqa

   Akums Drugs& Pharmaceuticals Ltd

   Apr 2022 — Present · Haridwar, IN

   Prepare & review software validation documents like URS, IRA, FS, FRA, OQ & PQ as per regulatory REQUIREMENT & execute and review the qualification (UAT, OQ & PQ) data as per pre approved protocols. Post implementation & Periodic review of GxP system to keep the system compliant as per GAMP 5, 21 CFR part 11 requirements.Preparation of corporate policies, standard practices & directives as per Regulatory amendments and ensure the implementation of the same. Implementation & reviewing of quality systems, standards and procedure be followed as per cGMP, GDP, GLP, other regulatory guidelines. Monitor and validate the computer system followed by referring GAMP 5 Guideline, PIC/s 2011, 21 CFR Part 11, EU Annexure 11 & Guidelines on Data Integrity. Review electronic generated data and audit trails for various server based and stand-alone systems viz. LIMS, HPLC, GC, UV, etc. to ensure data integrity and compliances. Sound working knowledge in SAP QM, PM, MM module. Rreview and participate in investigations of OOS/OOT and incidents/Deviation to find out the root cause and ensure the adequacy of investigation, documentation and CAPA.To perform the internal audit with CFT.To perform the vendor audit based on vendor quality score and produce report & prepare the vendor audit planner. Review and approve the stability sample management, Stability protocols and reports. Review and approve the analytical method validation, method transfer protocols and reports.To review and assess the change control, temporary change control and deviation. Review and approve of specification, STPs, GTPs and analytical Lab related SOPs and implement the pharmacopoeia changes.To evaluate and perform gap analysis of FDA 483s, warning letters and regulatory observation. Involvement in the regulatory audit of the quality system and initiation as well as follow up action of corrective action.Planning and work allocation as per requirement and schedule.

Education

• Agra college, agra

  Master's degree

  2001

Skills

• Quality Assurance
• Good Laboratory Practice (Glp)
• Quality Control
• Gmp
• Hplc
• Quality System
• Validation
• Pharmaceutical Industry
• Sop
• Biotechnology
• Regulatory Affairs