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Summary

A highly motivated and professional pharmaceutical quality assurance professional, 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.

Experiences

Current Experience

  • Executive Contract Manufacturing services Quality Assurance
    Since August 2015
    1. Quality Systems audits of manufacturing sites as Per Schedule M, WHO-GMP, US-FDA, EU GMP and Follow up for implementation of CAPA. 2.Quality System audits of Analytical labs. Co-ordination for testing of product samples at outside laboratory. 3. Quality system audits as per CDSCO, Good distribution services and Training to CFA, Hubs and Depots. 4. Artwork review & approval. 5. Involvement in Technology Transfer 6. Review of BMR, BPR & Batch release documents received from Manufacturing sites 7. Preparation & review of COA's ,Review of Analytical reports & Stability reports. 8. Co-ordination for FDA documents with Loan License & Third Party mfg. sites 9. Preparation & review of Validation protocols & reports. 10. Review & updating of product profile

Past Experience

  • Quality Assurance officer
    June 2013 --- July 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. 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 hold time study reports after completion of the study. • 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: •• 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 and Packing stages as per requirement. • Preparing and facing self-inspection, internal audits etc. • Immediate reporting of any non-compliance's and observations to the superiors through QA rounds. • Job assigned from time to time by Superiors.

  • QA Officer
    July 2011 --- June 2013
    • To observe follow of cGMP in Industry. • 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.

Personality

Self Assessment :
Attention to detailCoordinationCreative thinkingFlexibilityIndependenceProactivityProblem solvingResult Oriented

Knowledge

LinkedIn Assessment :
Quality AuditingPharmaceuticsValidationFormulationCleaning ValidationQuality AssuranceGMPPharmaceutical IndustryGLPChange ControlR&DFDARegulatory submissionsRegulatory affairsCAPAMHRAHold time StudyGXPRegulatory Requirements21 CFR Part 11Pharmaceutical ResearchGCPPharmacokineticsOOSQuality SystempharmacologyQuality ControlProduction ManagementQuality Assurance Reviewquality documentationSOP developmentSOPSix SigmaQuality ManagementLean ManufacturingLean Six SigmaContinuous ImprovementChange ManagementMicrosoft OfficeSAPTrackwiseMicrosoft ExcelMicrosoft WordMicrosoft WordEnglishTeamwork

Skills and Expertise

Self Assessment :
Create SOPs Write protocolsArchive documentationAseptic techniquesAssure medical qualityCoordinate recallsDesign protocolsEnsure data integrityFollow-up of external auditsFollow-up of internal auditsFollow-up of Quality Management System (QMS) processesFollow-up of quality assurance activitiesHandle incidentsImplement Quality Management System (QMS)Quality control processRelease productsReview dataReview manufacturing documentationTrain StaffWork cross-functionallyWork under specific instructions

Education

  • Bachelor of Pharmacy (B.Pharm.) in Pharmaceutical Sciences from University of Pune in 2011
  • Diploma in Pharmacy in Pharmacy from SLSA Pharmacy College, Nanded, Maharashtra, India in 2008
  • Higher secondary school certificate in Basic from KKM College, Parbhani,Maharashtra, India in 2006
  • Secondary school certificate in Science from MPHS, Vijay Nagar, Nanded in 2004

Training and Certification

  • Certified for Conducting GMP Audits Effectively Certification
  • Lean Six Sigma Green Belt Investigator Certification

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency

Work Preferences

  • Notice Period:
    4 weeks
  • Positions I am interested in:
    Quality Assurance (QA) Manager Quality Specialist operational excellence change agent
  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    Permanent position :    100% FTE
    BrightOwl employee :    100% FTE
  • International:
    Yes

Area / Region

India

Others

Driving License
  • No