Quality Assurance Management

Mona Patel

contact: et84ow@r.postjobfree.com

Cell: 408-***-****

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SUMMARY of Qualifications:

• A combined experience in Quality Control, Quality Assurance, Manufacturing Operations and Quality Compliance in a GMP and FDA regulated industry.

• Good knowledge of biotech manufacturing, testing, validation, cGMPs and FDA regulations.

• Experienced in training new employees and motivating staff to attain goals.

• Highly effective verbal and written communicator.

• Proficient in Microsoft Word, Excel, SAP, Trackwise System, Power Point and Electronic Document Management System and LIMS/Citrix System.

• Specializing in processes of NC/CAPA, Change Controls, Project Management, Management Reviews and document revisions.

EXPERIENCE:

Manufacturing Specialist-Boehringer-Ingelheim/Amgen, Inc. Fremont, CA (06/09-Present)

• Mfg NC/CAPA Program owner and Change Control owner.

• Develop and Maintain SOPs for Mfg process-Participated in the document redesign project, cross-site Amgen initiative, as an SME for Mfg process improvements.

• Participated in Process Improvement Projects: Kaizen, OPEX-Operational Excellence and Organizational Design and Capabilities (ODC) project.

• Mfg representative on the Product Complaint team. Work with Site and Corporate Process Development groups in writing Study Protocols and implement investigational studies.

• Manage the gowning qualification and requalification program for the Filling Operators.

• Facilitates Mfg monthly Functional reviews and represent Mfg in site Management Reviews. Manage the Amgen Fremont/BIFI Mfg Autonomous Readiness program for inspection readiness.

• Regulatory/Internal Inspection Support (FDA, State, Corporate, EMA and potential clients).

• Work with Process Development in Pilot plan projects: developing a fill and finish process for new molecules.

Amgen, Inc –QA/QC Senior Associate Fremont, CA (01/07- 06/09)

• Lead QC in performing and reviewing detailed investigations for NCs and execute CAPAs in response to deviations. QC Representative in Triage meetings to provide updates on NCs/CAPAs and working with QA to properly classify the non conformances. QC Change Control owner.

• Lead QC in of authoring QC EM trend reports on Quarterly and Annual basis. Responsible for reviewing data pertaining to WFI, Clean Steam and Environmental Monitoring in the production area under cGMP standards. SOP development and maintenance.

• Generate metrics for monthly management review. QC Group Performance Board Owner: Update the performance board on a monthly basis for management walk-through.

• Evaluate the BMS data for the equipments for QC EM group and generate weekly and quarterly reports for the lab equipments. Implement any corrective action to address the critical alarms.

• Active member of the Internal Audit cross functional group since 2008. Conducted internal audits to maintain an inspection readiness state

• QA Lot Release: Reviewed Mfg batch records, released QC raw materials, drug product disposition, and reviewed equipment trend reports.

Allergan, Inc. - QC Analyst/QA-QC Analyst Campbell, CA (10/04-12/06)

• Perform internal audits of Manufacturing, QC chemistry and Logistics department. Author audit reports and work with impacted departments to close the audit observations.

• Perform validation of Vitek Automated System.

• Responsible for reviewing data pertaining to WFI, Clean Steam and Environmental Monitoring in the production area under cGMP standards

• Perform specific potency testing (LD50) at the contract labs for the batch release. Work with contract lab for scheduling testing for batch release.

• Train and Qualifying analysts on the following assays: Gowning, Sterility, Bioburden, Conductivity, EM sampling and Potency testing.

• Perform Water collection, Bioburden testing, endotoxin testing and chemistry testing. Perform Environmental Monitoring. Raw Material release: Receive, test and release media and other lab supplies for general lab purposes.

Collagen Aesthetics/Inamed-Microbiologist/Senior Microbiologist Fremont, CA (06/95 -02/01)

• Improved analytical methods resulting in increase of efficiency, efficacy and economy. Participated in the validation of analytical methods. Develop HELIX EM database system.

• Performed Sterility, LAL, Bioburden and Environmental Monitoring testing of commercial and clinical material. Received, inspected, tested and released media for general lab purposes.

• Wrote and revised Standard Operating Procedures for various microbiological assays as per compendial and in-house specifications. Lead the site Safety Committee.

Systemix Inc. -QA Assistant Palo Alto, CA (03/95 -06/95)

• Performed EM, WFI testing and microbial identification of organisms. Perform general lab work.

Bee-Pharmo Labs- Lab Technician Bombay, India (06/92 -06/93)

• Prepared reagents, media and calibrated pipettes and thermometers. Received and distributed samples to the labs and inventory control of unused samples.

EDUCATION PROFESSIONAL DEVELOPMENT:

• B.S., Microbiology, University of Bombay, India

References Available Upon Request

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