Qc Manager Chemist
Resume:
Hajee Mohamed
NY *****
****************@*****.***
PROFESSIONAL EXPERIENCES:
AUGUST 1998 TO OCTOBER 2022
LNK QUALITY CONTROL DIRECTOR
LNK INTERNATIONALINC., HAUPPAUGE, NY
Quality Control- In charge of 60 chemists, four supervisors, 4 microbiologists…
• Oversees ongoing on-site training program for corporate SOPs, Quality Control Operating Procedures (QCOPs), and off-site training as well as conducting cGMP and test procedure training. Document all training.
• Review all QCOPs, specifications of raw materials, and finished product COAs.
• Write corporate procedures related to Quality Control.
• Oversee the raw material and finished product release process so that the release of raw material and finished product are conducted as per schedule and randomly review the completed records of both as well as review analyst book.
• Oversee the stability program and monitor the stability testing to ensure the testing is done in a timely manner. Review the stability chamber and stability room charts weekly.
• Oversee the lab instrument calibration to ensure that all the lab instruments used are calibrated as per lab procedure.
• Oversee daily monitoring of purified water systems.
• Write investigation reports for out of specification results.
• Oversee lab chemical and solvent inventory.
• Oversee microbiology laboratory day-to-day operation and review microbiological laboratory investigations.
• Review process and cleaning validation protocols and summary reports.
• Oversee analytical method development and validation.
• Conduct contract lab and API vendor on-site audits domestic and international.
• In charge of micro lab which perform micro tests for water samples, solid and liquid products, USP<61> and <62> microbiology suitability.
• In charge of 10 purified water systems.
• In charge of R&D lab.
OCTOBER 1994 TO AUGUST 1998
QC MANAGER
2
HALSEY DRUG COMPANY, BROOLYN, NY
.
• In charge of QC lab, R & D lab and micro lab, 45 chemists, 3 supervisors and microbiologists.
• Oversee raw materials and products testing and release process’
• Oversee analytical method validation of release and stability samples, review protocols and summary reports.
• Write SOP, test procedures and OOS investigation.
• Conduct GMP, SOP and test procedure training.
• Oversee instrument calibration program.
• Review process validation and cleaning validation protocols and summary reports, oversee process validation testing.
• Prepare lab documents for ANDA submission.
November 1977 to September 1994
Biocraft Laboratories (Teva Pharmaceuticals)-
QC Chemist, QC Supervisor, QC Manager
• In charge of 22 chemists, three supervisors, 1st and 2nd shifts.
• Oversee method validation of finished product and stability samples.
• Write Lab SOPs, test procedures, method validation summary reports.
• Conduct lab investigation for OOS results.
• Oversee stability testing and instrument calibration
• Oversee finished product and raw material release.
• Prepare lab documents for ANDA submission.
EDUCATION
MS Pharmacology Madras University, India.
BS Chemistry Madras University, India
SKILLS
• Audits
Since 2000, contract lab and API vendor audits were conducted. Contract labs include SGS Life Science (616 Heathrow Dr IL 60069), Alcami Lab (St. Louis), Curia Lab
(formerly White House Labs), Sannova Lab, Stira Lab in New Jersey, Accuon Labs and Stiefel Labs in New York, and Eurofins in Madison, WI.
• API Vendor Audits
Domestic- BASF, Albemarle (currently AI Pharma), Adare, Chattem, Mallincrkodt. International- Audits were conducted in Italy, Germany, France, and India. FDA and Customer Audits
3
Involved in several FDA and customer audits in Biocraft Laboratories, Halsey Drug Company, and LNK International, Inc.
• Excellent skills in written and verbal communication of detailed technical information and research strategies, effective interpersonal skills in coordination and organization of internal and external resources for materials testing, and skilled in analysis of data and application of statistical tools.
• Experience directing Quality Control programs for method transfer, method validation, in-process testing, drug product testing and stability testing.
• Microsoft Office
• Experience in preparing ANDA filing documents, annual product review through eCTD and FDA preapproval inspection.
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