Quality Executive
Resume:
MOHAMED FAROOK ABDUL GANI
MONMOUTH JUNCTION
NEW JERSEY-08852
CELL: 732-***-****
Email Id: **********@*****.**.**
*******@*****.***
Objective
Keywords: Highly motivated, results-driven Supervisor having 7 years of R&D experience and 9 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 16 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, Empower, MS office Suite. Lupin Somerset (Novel Laboratories Inc), Somerset, New Jersey (Jan 2011 to present) 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. MOHAMED FAROOK ABDUL GANI
1001 NORTHUMBERLAND WAY
MONMOUTH JUNCTION
NEW JERSEY-08852
CELL: 732-***-****
Email Id: **********@*****.**.**
*******@*****.***
• 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. MOHAMED FAROOK ABDUL GANI
1001 NORTHUMBERLAND WAY
MONMOUTH JUNCTION
NEW JERSEY-08852
CELL: 732-***-****
Email Id: **********@*****.**.**
*******@*****.***
• 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. MOHAMED FAROOK ABDUL GANI
1001 NORTHUMBERLAND WAY
MONMOUTH JUNCTION
NEW JERSEY-08852
CELL: 732-***-****
Email Id: **********@*****.**.**
*******@*****.***
● 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 from Jamal Mohamed College, Tiruchirappalli, India. 1997-2000 Bachelor of Science from Jamal Mohamed College, Tiruchirappalli, India.
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