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Summary

Focused & goal driven with strong work ethics, continuously striving for improvement coupled with commitment to offer quality work 5.6 years of Overall Experience in pharmaceutical industry, formulation development, & Quality Management system

Experiences

Current Experience

  • Compliance Executive
    Since April 2015
    - Reviewing Concordia product range against relevant Pharmacopoeias to ensure compliance. - Reviewing the Concordia product range against registered information and identify the gaps and raising Change Controls as required in order to close the gaps identified. - To be a part of routine Pharmacopeial updates and ensure that all the registered/ manufacturer documents are as per current pharmacopoeia. - Prepare and Review of Manufacturing Compliance Documentation (MCD’s (Registered Information) to be sent to Third Party Manufacturers (TPMs). - Issuing MCD’s to Third Party Manufacturers and resolving any queries/ ad hoc requests. - Reviewing and approving Master Batch Manufacturing and Packaging Instructions and Specifications received from TPMs as and when required. - Ensuring adherence to documented company procedures. - Any other compliance activity as and when it comes as per the business requirement.

Past Experience

  • R&D Scientist
    June 2013 --- April 2015
    • Assuring Quality in formulation and development of oral solid dosage form, with its regulatory compliance to various markets like UK, USA, Canada, Australia, and Europe is the prime responsibility at R&D work-space Role & Responsibility: Preparation of Master production & Control Records (MPCR) Preparation of Batch production & Control Records (BPCR) Preparation of Quality Assurance Documents & SOP Preparation of Specification, Standard Testing procedure & COA of API & Raw materials Preparation & Evaluation of Annual Process Quality Reports (APQR) Preparation & Evaluation of Stability Study Report Evaluation of Reference standard & Characterization Data Responding the post PDR, PVP, MPCR, BPCR submission queries Evaluation of Vendor qualification Knowledge of CTD/QBD Format for preparation of PDR Knowledge of ICH Guidelines Evaluation of Analytical Method Validation Report (AMVR) - Related Substance - Assay, dissolution - Residual Solvents - Force degradation Study, Carryover study, cleaning validation

  • Production officer Kopar Khairane, Navi Mumbai, Maharashtra, India
    November 2010 --- August 2011

    • Execution and control monitoring of different ANDA pre exhibit & Exhibit batches for USA &UK market. • A comprehensive monitoring of solid oral drug facility on account of quality of the product. • Preparation and execution of Process validation protocol, Analytical method validation protocol, Stability protocol, Drug-excipients compatibility study protocol, and hold time protocol. • To perform in process sampling and analysis with use of sophisticated instrument at various stage of manufacturing. • Responsible for Batch coding approval, in process checks, Final inspection, control sample and stability sample withdrawn during packing. • To prepare & review Analytical record and release the batches. • Maintains the status and review of event and Incidence investigation reports. • To co-ordinate predefined frequencies calibration for IPQA instrument & analytical equipments • To help the lead investigator to find out root cause & subsequent CAPA for market complaint and deviation. • Perform impact analysis for various changes & deviations on quality system. • SAP data entry. • Application of Licenses for, Innovator & API Import licenses, Manufacturing Licenses, Test licenses, Additional Products, Test license & Manufacturing Licenses NOC’s, Renewal of licenses.

  • Production officer
    December 2009 --- November 2010

    • Daily monitoring the Production Activities and good working knowledge of performing batch process. • Daily updating of Manufacturing Planning & sharing the planning to my subordinates. • Achieving daily production target along with operating staff. & Supervising team off operating staff and workers. • Coordination with QA, QC, Stores, & Maintenance for smooth Production Activities in time. • To carry out the Calibrations of equipment’s as per the schedule & maintain the records. • To maintain the on line documentation in Process Areas under cGMP • Line clearance for next product or next batch of the same product. • Responsibility for quality and yield of the formulation • Involvement in the process validation, cleaning validation, equipment validation/qualification and non routine validation along with quality assurance personnel.

  • Production officer
    June 2009 --- December 2009

    • Daily monitoring the Production Activities and good working knowledge of performing batch process. • Daily updating of Manufacturing Planning & sharing the planning to my subordinates. • Achieving daily production target along with operating staff. & Supervising team off operating staff and workers. • Coordination with QA, QC, Stores, & Maintenance for smooth Production Activities in time. • To carry out the Calibrations of equipment’s as per the schedule & maintain the records. • To maintain the on line documentation in Process Areas under cGMP • Line clearance for next product or next batch of the same product. • Responsibility for quality and yield of the formulation • Involvement in the process validation, cleaning validation, equipment validation/qualification and non routine validation along with quality assurance personnel.

Knowledge

LinkedIn Assessment :
Regulatory affairsSOPValidationHPLCV&VCleaning ValidationTechnology transferGMPPharmaceutical IndustryFormulationPharmaceuticsTeam ManagementR&DQuality SystemGLPBiotechnologyFDALife SciencesDrug DeliveryDissolutionQuality AssuranceChromatographySOP

Skills and Expertise

Self Assessment :
Expertise in regulatory complianceHandling QMS like Change controldeviationstabilitybatch releaseSOP handling. Analytical skills Create SOPs Write protocolsApprove consent documentsApprove monitoring reportsArchive documentationAssist with proceduresAttend seminars

Education

  • Master's Degree in Pharmaceutical Sciences & Quality assurance from University of Pune in 2013
  • Bachelor's Degree in Pharmaceutical Sciences from University of Mumbai in 2009

Training and Certification

  • computer excellence Certification

Languages

BrightOwl Assessment:
Self Assessment:
English
Professional Proficiency
Hindi
Native

Work Preferences

  • Notice Period:
    4 weeks
  • Positions I am interested in:
    quality system executive Associate Scientist Data Reviewer Formulation scientist GMP Coordinator GMP Operator Industrial Pharmacist Junior Scientist Lab Analyst Operations Pharmacist Project Assistant QA Consultant QA Officer QC/QA Manager R&D Scientist Regulatory Affairs Associate Regulatory Affairs Assistant Research associate
  • Locations I am interested in:
    France Germany Ireland Netherlands Spain United Kingdom
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    70% FTE
  • International:
    Yes

Area / Region

India

Others

Driving License
  • No