NIKHIL POKALWAR
1-5-1021, Ganesh Nagar, Nanded, Maharashtra 431602 • H: - • C: - •-
PROFESSIONAL SUMMARY
A highly motivated and professional quality assurance officer, capable of delivering at highest level,
effective team player and capable of engaging and liaising with broad range of individuals from
variety of backgrounds. My professional experience to date has provided wealth of specialist skills
and expertise and I am committed to facing fresh challenges and to pursuing my future career
goals.
SKILLS
CGMP Software's Handled - SAP,SOFT SKILLS –Positive attitude, team player,
Track-wise.good communication skills, self-confidence.
Proficient in applications like MS-Office,BEHAVIORAL SKILLS – Initiative, problem
MS-Excel, MS-Word.solving, decision making, ability to follow
instructions.
CERTIFICATIONS
Certified Lean six Sigma Green belt Investigator.
Attended two days certified training on “Conducting GMP Audits Effectively”.
WORK HISTORY
Executive Quality Assurance
WOCKHARDT LIMITED - Mumbai, Maharashtra, India08/2015 - Current
Audit, review & compliance of manufacturing plant, new facility and routine audit of
manufacturing plant of solid oral/ Liquid/Dry powders/ Topical preparations.
Routine audit of warehouse and depot(HUB).
Audits of Analytical labs and Co-ordination for testing of product samples at outside laboratory
Handling of market complaints, Change Control and Deviation Management.
Handling of recall and related activities.
To coordinate MRP communications to Manufacturing site.
Preparation and review of BMR, BPR of Tablet, Liquid and topical dosage forms
Review of batch release documents and APQR/APR.
Review of BMR, BPR and Batch release documents received from manufacturing sites.
Preparation and review of COAs.
Co-ordination for FDA documents with LL and TP mfg. sites
Artwork review and approval.
Preparation and review of Validation protocols and reports.
Officer Quality Assurance
Watson Pharma Pvt Ltd - Panjim, Goa, India06/2013 - 07/2015
Opex Change agent:
To support Value Stream Coach and Value Stream in implementing lean transformation and
daily management across value stream.
To act as change agent to bring about improvements in manufacturing process through active
support, participation and leadership of Rapid Improvement Events
Executing key activities as part of Lean Transformation and daily management
To support launch of all activities needed to incorporate Lean Transformation and daily
management into the Value Stream culture.
Track all changes/improvements made to provide Value Stream Leadership/Management the
assurance that changes are effective and lasting.
QMS activities:
Preparation and Review of SOP's
To handle Change control and Deviation management.
To assist in Market complaint Investigation
To Handle Self Inspection (Internal Audit) activities including Scheduling, follow up for CAPA.
Review of filled BMR's and BPR's of Pre-exhibit, Exhibit, Validation and Commercial Batches in
each stage.
Issuance of BMR's and BPR's to production and Packaging department upon receipt.
Review of Punch Inspection records.
Hold Time Study activities:
Responsible to perform 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
Preparation of hold time study reports after completion of study.
Co-ordination with RA for submission of hold time study reports
Officer Quality Assurance
Unichem Laboratories Ltd. - Pilerne Industrial Estates, Goa, India07/2011 - 06/2013
To control and 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 IPQA related equipment's.
To perform cleaning verification Sampling.
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 labelling 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.
ACHIEVEMENT'S:
Successfully reduced product cycle time by minimizing intermediate product testing
requirements.(Approx. Saving – 200000 USD)(Got appreciation Certificate for same)
Successfully reduced consumption of water from 08 Kl to 05 Kl daily, thus reducing pressure
on ETP Plant.
Increased warehouse capacity, around 300 pellet capacity by using 5S techniques
Reductions in Expense of Packaging material by using 5 ply shippers instead of 7 ply
Shippers.(Approx. Saving – 20000 USD)
Used 5S concepts to various processes in Quality Control Lab to reduce total testing time.
Use of online Application Such as SAP for tracking documents
EDUCATION
Bachelor of Pharmacy: Pharmacy
University of Pune - Pune, Maharashtra, India2011
Presented total 05 No's of Posters in Various National Level Conferences.
Diploma in Pharmacy: Pharmacy
SLSA college of Pharmacy - Nanded, Maharashtra, India2008
