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QA Supervisor Operations

Elmont, New York, United States
December 24, 2015

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Vikas Saini

Hicksville, NY *****516-***-**** •


7+ years of experience in Quality Assurance in pharmaceutical industry, ensuring compliance of diverse capsule, bottle and tablet filling/packaging/labeling equipment to GMP, FDA & OSHA regulations.

FOUGERA PHARMACEUTICALS INC. (A Sandoz Company) - Hicksville, NY Nov 2011 – Present

QA Supervisor (Operations)

Assisted executive level management in achieving zero write-ups for the entire production floor during the 2013 FDA audit, getting entrusted permanent responsibilities as management representative for future third party, customer and regulatory agency audits

Led cross functional team of eight members, from multiple Novartis subsidiaries, at Novartis’ biggest warehouse to ensure 100% quality assurance of an anti-cancer drug from third party Asian supplier

Trained 30+ associates from multiple departments to confirm compliance to an emergency incident protocol, ensuring timely product launch of a $100M/year product

Assisted Investigation Manager to resolve a critical market complaint that had resulted in stoppage of five production lines for six months

Awarded for leading a team, which timely detected and resolved critical issues in the batch folders of a major product avoiding market recall of $500K+

Selected to lead the first Safety team to conduct monthly OSHA audits for Fougera’s Melville location. The team reduced safety incidents by 33% in its first year

Chosen by VP of Quality Operations to develop and supervise GMP training of QA operations staff to ensure compliance with SOP, safety standards, and Sandoz’s SAP based incident QC reporting system

Identified and prepared CAPA with a closure rate of 100% for critical defects for the last calendar year in all manufacturing operations and documentations

Supervise daily activities of six QA associates including line assignments, training and AQL documentation review of eight production lines with annual production capacity of $175M+

Approve validation protocols, and investigation closure reports for production lines at both of Fougera’s locations to ensure timely release of production batches for domestic and international markets

Formulate and maintain department specific quality objectives complementary to corporate policies and goals.

Ensure full compliance with all manufacturing activities within the plant including (Dispensing, Warehousing, Compounding, Packaging, Distribution).

Review and approve all operational Impact Assessments, SOPs, Protocols (IQ/OQ/PQ), Validation Documents (Manufacturing/Packaging/Bulk Hold/Temperature Studies) and Change Controls within the EDMS.

Facilitate investigations relative to the DDI/LIR/CAPA processes.

Manage activities assigned within Trackwise to aid in the closure of DDI/LIR/CAPA.

Manage batch statuses of raw materials, bulk product and finished product within the ERP system.

Review and approve all critical calibration change control and Out of Tolerance (OOT) notifications.

Review and approve all operational Maintenance and Repair log entries and Preventive Maintenance additions and extensions.

Assure compliance with all Regulatory agency guidelines (e.g. FDA, ICH, OSHA) as well as assist with FDA and internal audits.

Manage the QA Compliance Walkthrough program.

Help implement Quality Culture initiatives such as the Quality Modules and the Quality Directives.

Develop Staff- Maintain Talent Management System Profiles for self and staff to aid in this process.

Adhere to all applicable procedures, cGMP’s, company policies, and all other Quality or Regulatory requirements (OSHA, DEA, FDA, HS&E, and USP/NF etc.).

Ensure all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory standards, and departmental, plant, and corporate Quality and Behavioral Based Safety (BBS) goals.

AUROLIFE PHARMACEUTICAL - Dayton, NJ Jan 2010 – Nov 2011

QA Team Lead

QA Shift in-charge ensuring quality compliance for a production facility of 200K+ packed bottle units

Assisted QA Manager during FDA/OSHA inspections, and reviewed and filed investigations to improve internal manufacturing activities

Selected by Director of Quality to develop interactive trainings for QA SOP procedures

Assured cleanliness of packaging lines and compounding equipment, conducted in-process and finished product inspection surveillance, validated equipment calibrations and authorized batch rejections

FOREST LABORATORIES – Hauppauge, NY Oct 2007 – Sept 2009

QA Associate

Ensured quality compliance of raw materials received; conducted in-process and final product sampling; and approved release of final product to the customer

Audited manufacturing operations and closed an average 90% investigation reports for monthly deviations

Collaborated with cross-functional teams of multiple products to ensure compliance of Phase 1-3 clinical trials to FDA regulations, ensuring timely market launch

AWARDS AND RECOGNITION – Recipient of Estee Lauder annual scholarship.

EDUCATION – Bachelors in Bioscience, Farmingdale State College (Dec 2015)

D-Pharm (Karnataka, India)

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