Quality Assurance Executive

Name : NIKHIL K. POKALWAR

Address : Ganesh Nagar, Nanded-431602, Maharashtra, India

Mobile : +91-956*******

Email : *********@*****.***

Date of Birth : 12-06-1988

PROFILE

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.

KEY KNOWLEDGE SKILLS AND EXPERTISE

SOFT SKILLS –Positive attitude, team player, good communication skills, self-confidence.

BEHAVIORAL SKILLS – Initiative, problem solving, decision making, ability to follow instructions.

OPERATIONAL SKILLS – Erweka Multicheck tester, Digital weighing Balance, Disintegration Test apparatus, Friability apparatus, Hardness tester, UV-Spectrophotometer, Leak Test apparatus, Moisture analyzer IR and Halogen, Tap and Bulk Density Apparatus, Tablet Moisture analyzer, Electromagnetic sieve shaker, Torque meter.

PROFESSIONAL EXPERIENCE

Wockhardt Pharmaceuticals Ltd., India Executive Quality Assurance Aug.2015 to Present

Quality Audits of 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.

Market Complaints Investigation and follow-up for the CAPA.

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 for FDA documents with LL & TP mfg. sites

Preparation & review of Validation protocols & reports.

Review & updating of product profile.

Watson Pharma Pvt. Ltd., Goa, India Officer Quality Assurance Jun.2013 to Jul.2015 .

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.

Contd.

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.

Unichem Laboratories Ltd. Officer Quality Assurance Jul.2011 to Jun.2013

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

Other Customer Audits.

PROFESSIONAL QUALIFICATION AND EDUCATION

Qualification

Institution

Year

Bachelor of Pharmacy

University of Pune, India

2011

Diploma in Pharmacy

SLSA college of Pharmacy, Nanded, India

2008

Higher secondary school Certificate

Mahatma Phule high school, Nanded, India

2006

Secondary school certificate

KKM college, Manwath, India

2004

COMPUTER SKILLS

Software’s Handled - SAP, Track wise.

Proficient in applications like MS-Office, MS-Excel, MS-Word.

TRAININGS

-Certified Lean six Sigma Green belt Investigator.

-Training taken in Yellow belt lean six sigma

REFERENCES

References will be given upon request.

Contact this candidate