Maintenance Manager

Hurmat Hussain

*** ***** **** *****

Indianapolis IN 46227

Cell: 317-***-****

Home: 317-***-****

E-mail address: ************@*****.***

OBJECTIVE:

A Metrologist/chemist or Relevant position within a highly competitive company that offers the opportunity for personal and professional growth.

QUALIFICATIONS:

• Excellent lab instruments Qualifications, Calibrations and Maintenance skill.

• Metrology and Compliance, Instrumentation Section coordination.

• Strong knowledge of laboratory instrument/system qualification and troubleshooting.

• Excellent Knowledge about the different laboratory system software (Empower, Track Wise, LIMS, Beckman LS 13 320 for particle analysis, Severs TOC.

• Ability to adapt and think out side the box to come up with unique answers to difficult situations

• Excellent in planning and multitasking.

EMPLOYMENT HISTORY

WATSON LABORATORIES USA Sr. QC Metrologist 11 / 2006 - 05/2009

• Performed maintenance on different lab instruments HPLC, UV, Dissolution baths, FTIR, DSC, TGA.

• Performed Calibration and qualification (IQ, OQ, PQ) of various lab instruments.

• Revised SOPs for the laboratories Instruments.

• Entered and Review the calibration and validation data and management of laboratory related information within the sites calibration maintenance management system (Cal manager).

• Revised different instruments operational, maintenance and calibration procedures and provided assistance in the implementation of IT tools for laboratory operations.

• Worked with lab supervisors to identify root cause and corrective actions related to Out of Tolerance Results (OOT).

PATHEON CINCINNATI, OH. USA Analytical Chemist/Metrologist (Contractor) 06/ 2005 – 06/2006

• Performed Chemical Analysis (assays, content uniformity, impurities) of Pharmaceutical Finished products (Tablets and capsules).

• Performed HPLC maintenance, repair and trouble-shooting.

• Performed monthly Lab Audit.

• Performed analysis of raw material.

AMERICAN PHARMACEUTICAL PARTNERS, IL. USA. Sr. Analytical Chemist 11/ 2004 – 06/ 2005

• Performed Chemical analysis of in-process and finished pharmaceutical products for Oncology.

• Performed second person verification for the lab analytical reports.

• Wrote and reviewed qualification protocols for lab equipments and instruments.

• Performed monthly Lab Audit.

• Wrote and reviewed investigation and deviations for OOS/OOT results.

• Reviewed the instrument’s logbooks per QA SOPs, and regulatory guidelines (FDA, USP and ICH)

• Provided technical assistants and training to the lab staff for instrument operation and troubleshooting.

ELI LILLY & CO. IN. USA. QC for QCL (Contractor), 04/2003-10/2004

• Reviewed and approved Qualifications/Validation protocols of the Chemistry and Microbiology labs equipments/ Instruments per FDA, ICH and USP guidelines. Evaluated results and prepared a final report to allow release of laboratory instruments and stability chambers.

• Worked with different contractors and lab staff to write and execute CSV, IQ, OQ and PQs for Micro and Chemistry lab instruments.

• Provided technical assistants and training to the lab staff for instrument troubleshooting.

• Provided assistance in the execution of technology transfer plans related to equipment qualification (IQ, OQ and PQs).

• Worked with laboratories investigations team to address and improve laboratory equipment and Results reliability.

WYETH PHARMACEUTICAL, NY. USA- QA Specialist 01/ 2002 – 04/2003

• Performed Lab equipment/instruments Calibration analyzed the results, prepared the final summary reports.

• Generated monthly/annual Laboratory Instruments Calibration Schedule.

• Develop and execute initial Qualification protocols (DQ, IQ, OQ and PQ) for new and relocated instruments.

• Participated in internal audits.

• Developed and revised SOPs for the laboratories Instruments

BIOVAIL TECHNOLOGIES, VA Metrologist 09/2000- 03/ 2002

• Performed maintenance on different lab instruments HPLC, UV, Dissolution baths, FTIR, DSC, TGA.

• Performed Calibration and qualification (IQ, OQ, PQ) of various lab instruments.

• Performed Thermal Mapping and temperature studies (by using Kaye validator) for Stability chamber, Incubators, Refrigerators and freezers ,Ovens Water bats and other temperature control equipments

• Developed and revised SOPs for the laboratories Instruments.

• Entered the calibration and validation data and management of laboratory related information within the sites calibration maintenance management system (Cal manager).

• Developed different instruments operational, maintenance and calibration procedures and provided Assistance in the implementation of IT tools for laboratory operations.

• Worked with lab supervisors to Identifies root cause and corrective actions related to Out of Tolerance incidents (OOT).

TRAINING/CERTIFICATION COURSES:

• Certified from waters for HPLC Maintenance and troubleshooting.

• Dissolution bath, Auto-plus and media mate troubleshooting and preventive maintenance certificate course from Hanson Research.

• GMP, cGMP, and GLP training at Novopharm.

• Water treatment technology certificate course from Swan Water Treatment

Technology (England)

References: Available upon request.

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