Quality Control R D
Resume:
Objective
Keywords: Highly motivated, results-driven Supervisor having 7 years of R&D experience and 14 years of Quality control management experience with master’s degree in Science. Managed a team of 20 QC personal to oversee quality as a Supervisor.
Method development and validation, cGMP, FDA, ICH, Preformulation, Method transfer, stability program, reference standard program, discriminatory and biorelevant dissolution procedures.
Over 21 years of overall R&D and QC experience in prominent pharmaceutical companies.
Developed and validated analytical methods for the spectrum of dosage forms.
Projects were due-diligently managed from the early development phase to till the commercialization.
Provided effective and timely support to Market complaints.
Keeping current with FDA & ICH guidance.
Technical Proficiencies: Track wise, SAP, QMS, LIMS, Empower, MS office Suite.
Granules Pharmaceuticals, Inc., Chantilly, Virginia (Nov 2020 to present)
Position: Team Lead & Manger (Quality Control)
Responsible for Managing site QC/Product launches/ Validations/Quality activities and staff.
Planning of work allotment to Chemists and reviewers. Monitoring analysis of In-process samples, Finished product samples, Validation samples, cleaning verification samples and Stability samples.
Coordinate with other departments for the scheduling of analysis and release in- process and finished products.
Review Quality related metrics and reports and undertake corrective measures regarding productivity and efficiencies.
Responsible for investigating OOS, OOT and Deviations in the Quality Control Department.
Review and approval of Deviations, Lab events, Market complaints, Change Controls, CAPAs, Process validation protocols and Cleaning verification/Validation programs, Software and Equipment qualifications/ validations.
Ensuring that Good Lab Practices are followed in the QC lab. Maintaining the QC lab as per OSHA regulations.
Approve the certificate of analysis for In-process samples, finished product and stability samples.
Monitoring of stability protocol preparation approval and execution. Planning for stability samples analysis, compilation of data and regulatory submission.
Ensuring that all the necessary sampling, testing and calibration is carried out as per the approved specifications and SOP’s.
Reviewing, updating and approving of general SOP’s and all instrument SOP’s related to Quality control department.
Reviewing, updating and approving STPs, GTPS and Specifications of In-process, Finish Product, Stability, API, Inactive, and packaging components.
Responsible for review and approval of Annual Product Review to see the product behavior in all aspects.
Training of the new employees or re-training of the old employees for Basic GMP Series.
Planning for samples sending to outside laboratory which are not possible to analyze in the department and checking of its records.
Monitor monthly indent of a list of required chemicals, glassware, columns, and other requirements.
Monitor Preventive Maintenance, Calibration and maintenance of the instrument.
Lupin Somerset (Novel Laboratories Inc), Somerset, New Jersey (Jan 2011 to Sep 2020)
Position: Supervisor & Group Leader (Quality Control)
Responsible for Managing site QC/Product launches/ Validations/Quality activities and staff.
Planning of work allotment to Chemists and reviewers. Monitoring analysis of In-process samples, Finished product samples, Validation samples, cleaning verification samples and Stability samples.
Coordinate with other departments for the scheduling of analysis and release in- process and finished products.
Review Quality related metrics and reports and undertake corrective measures regarding productivity and efficiencies.
Responsible for investigating OOS, OOT and Deviations in the Quality Control Department.
Review and approval of Deviations, Lab events, Market complaints, Change Controls, CAPAs, Process validation protocols and Cleaning verification/Validation programs, Software and Equipment qualifications/ validations.
Ensuring that Good Lab Practices are followed in the QC lab. Maintaining the QC lab as per OSHA regulations.
Approve the certificate of analysis for In-process samples, finished product and stability samples.
Monitoring of stability protocol preparation approval and execution. Planning for stability samples analysis, compilation of data and regulatory submission.
Ensuring that all the necessary sampling, testing and calibration is carried out as per the approved specifications and SOP’s.
Reviewing, updating and approving of general SOP’s and all instrument SOP’s related to Quality control department.
Reviewing, updating and approving STPs, GTPS and Specifications of In-process, Finish Product, Stability, API, Inactive, and packaging components.
Responsible for review and approval of Annual Product Review to see the product behavior in all aspects.
Training of the new employees or re-training of the old employees for Basic GMP Series.
Planning for samples sending to outside laboratory which are not possible to analyze in the department and checking of its records.
Monitor monthly indent of a list of required chemicals, glassware, columns, and other requirements.
Monitor Preventive Maintenance, Calibration and maintenance of the instrument.
Oversee CMC documents pertinent to submission batches for Regulatory filings.
Lupin Somerset (Novel Laboratories Inc), Somerset, New Jersey (Feb-2008 to Dec 2010)
Position: Senior Scientist in Analytical R&D and Method Validation
Developing stability indicating methods for assay, degradation using HPLC and UPLC for drug products, drug substances and validating the same as per ICH requirements.
Developing discriminatory, biorelevant dissolution procedures for various products using USP Apparatuses # 1, 2, respectively.
●Ensure procedures conform to appropriate standards of identity, strength, quality and purity for components, bulk and finished products, scale-up samples, process validation samples, cleaning validation samples, marketed stability samples, affiliate samples and international manufacturing samples.
Periodic review of analytical method for suitability of quality control use.
Investigations were carried out due-diligently with strong scientific basis.
Developing and validated cleaning methods as per the cGMP requirement.
Performing solubility and excipient compatibility study.
Handling control substances project worked as coordinator.
IQ, OQ and PQ for lab instruments.
Cleaning method validation by HPLC methods.
Matrix Laboratories Limited, Hyderabad, India (August-2007 to January-2008)
Position: Chemist (Senior Executive)
Developed stability indicating methods for assay, impurity using HPLC for drug products and drug substances and validating the same as per ICH requirements.
●Supported product development for pre formulation support, analyzing research samples for potency, impurities and dissolution.
Periodically reviewed and audited analytical records and notebooks for the accuracy.
Prepared Validation Protocols, reports for the ANDA filing.
Transferred analytical methods to Quality control as per the Protocol.
Prepared justification reports for the specification limits of impurities & degradation products in drug products.
Aurobindo Pharma Limited Research Centre, Hyderabad, India (Feb-2004 toJuly-2007)
Position: Research Associate
Developed analytical methods by HPLC for Assay, Related substances, and dissolution rate testing for drug products.
Evaluation of Pharmacopeial Forum and preparing method equivalence report of drug products.
Transferred analytical methods to the manufacturing locations as per the protocol.
●Validated analytical methods by HPLC for drug substances and drug products as per the ICH guidelines.
Periodically reviewed of standard test procedures and standard operating procedures for the final approval.
Preparing various test methods for Finished products assay, dissolution and Related substances.
Supporting FDA deficiency requirement for Regulatory affairs.
Performing Injection compatibility study.
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Educational Profile
2000-2002 Master of Science (Chemistry) from Jamal Mohamed College, Tiruchirappalli, India.
1997-2000 Bachelor of Science (Chemistry) from Jamal Mohamed College, Tiruchirappalli, India.
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