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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. - 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 science)" rel="nofollow">Protocol, Analytical Method Validation science)" rel="nofollow">Protocol, stability science)" rel="nofollow">Protocol, drug-excipients compatibility study science)" rel="nofollow">Protocol, and hold time science)" rel="nofollow">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 ManagementQuality 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 in 0000 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

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