Nikhil Pokalwar

  • Mumbai, India Maharashtra
Nikhil Pokalwar

Executive Quality Assurance

Summary

A highly motivated and professional quality assurance officer, capable of delivering at the highest level, I have first rate organizational skills and an ability to produce a consistently high standard of work. I am an effective team player and capable of engaging and liaising with a broad range of individuals from a variety of backgrounds. My professional experience to date has provided a wealth of specialist skills and expertise and I am committed to facing fresh challenges and to pursuing my future career goals.

Education

Education
2011

B.Ph

University of Pune

Work History

Work History
Mar 2015 - Present

Executive 03-08-2015 To Present

Wockhardt Limited
Mumbai, India EXECUTIVE Responsibilities: Quality Audits manufacturing sites and Follow up for implementation of CAPA. Audits of Analytical labs. Co-ordination for testing of product samples at outside laboratory. Audits and Training to CFA, Hubs and Depots. Artwork review & approval Involvement in Technology Transfer Review of BMR, BPR & Batch release documents received from Manufacturing sites Preparation & review of COAs. Review of Analytical reports & Stability reports. Co-ordination FDA documents with LL & TP mfg. sites Preparation & review of Validation protocols & reports. Review & updating of product profile.
Jun 2013 - Present

Officer

Pharma Pvt
Watson(Actavis). Ltd., Goa, India OFFICER Responsibilities: OpEx Change Agent: Problem Solving/Root Cause Analysis-To Use rigorous logic and methods to solve difficult problems with effective solutions. Probes all sources for answers, to see hidden problems. Lean & Six Sigma-With the tool of Lean & Six Sigma, it enables us to reduce waste, find the bottleneck of process, and enables us to be best in quality, compliance, customer service and cost. Project Management-Good at figuring out the processes necessary to get things done, how to organize people and activities, understands how to separate and combine tasks into efficient work flow, what to measure and how to measure it can see opportunities for synergy and integration where others can't, simplify complex processes, gets more out of less resource. Hold Time Study activities: Responsible to perform the Hold time study of Blend, tablets, Capsule and Coating solution. Preparation and execution of hold time study protocols for semi-finished and bulk finished product. Preparation of sampling schedule of hold time study samples. Review of Guidance document received from FRD. Preparation of hold time study reports after completion of the study. Preparation of summary report Co-ordination with the RA for submission of hold time study reports. Quality Documentation activities: Preparation and Review of SOP's. Review of filled BMR's and BPR's of Pre-exhibit, Exhibit, Validation & Commercial Batches in each stage. Issuance of BMR's and BPR's to production and Packaging department upon receipt. Review of Punch Inspection records. IPQA activities: Implementation and monitoring of SOP's as per cGMP. Performing In process during Manufacturing and Packaging stage. To verify and certify Line clearances during Manufacturing and Packaging stage. To carry out sampling of process validation sample, cleaning validation sample, stability and reserve sample in all Manufacturing stages as per requirement. Responsible for cleaning and calibration of IPQC instruments. Installation of Data loggers to the dispatch shipment. Preparing and facing self-inspection, internal audits etc. Immediate reporting of any non-compliances and observations to the superiors through QA rounds. Job assigned from time to time
Jul 2011 - Jun 2013

Officer

Unichem Laboratories Ltd
Goa, India OFFICER Responsibilities: To control & observe follow of cGMP in entire Plant. Review of filled Batch Documents. Validation sampling, Finished goods sampling of controlled sample, party sample & stability samples. To perform calibration of all IPQC related equipment's. To perform cleaning verification. To prepare and Review Standard Operating Procedures. To carry out in process checks as per respective BMR and BPR in production, packing, & recording of result in same. To maintain the reserve sample area on monthly basis. To give area and line clearance at all the stages of production, packing activity. To check temperature, humidity, pressure differential in critical areas. To ensure labeling in the entire plant. Review of equipment logbook and other related log book on monthly basis. Sampling of Intermediate, in-process, finished product and handling over sample to QC for testing. Sampling of bulk finish and finished packs and stability samples. Any other job Assigned by QA Manager. AUDITS ATTENDED USFDA MHRA Customer Audits.