Manager Manufacturing

PRAGNESHKUMAR SHAH

**********@*****.*** LINKEDIN –

PRAGNESH SHAH

MOBILE: 226-***-**** ONTARIO, CANADA

Operations Management Professional Pharmaceutical cgmp environments dea compliance

EXECUTIVE SUMMARY:

• Highly motivated and experienced Operations Manager with expert proficiency in managing all aspects of manufacturing in a high-

volume environment, with a focus on the production of generic pharmaceuticals

• Extensive expertise in solid oral dosage manufacturing in cGMP environments

• Demonstrated record of achievement contributing to operational goals and fostering productive, collaborative relationships with

team members and senior management; regarded for the ability to oversee the operations of multiple departments

• Successful in building highly effective teams of talented team members who contribute to the overall success of the organization

• Spearheaded in technical advisory role and participated in certification program during remediation of Consent Decree with the

FDA.

PRINCIPAL AREAS OF EXPERTISE:

• • •

Leading Projects

Production Planning/Operations DEA Compliance

•

• •

Qualification and Validation

Solid Oral Dosage Production Safety Planning

• Employee Training

• •

Budget Preparation/Administration Vendor Communication

• Technology Transfer

• •

Cost Containment QA for In Process/Quality Systems

• Change control/CAPA/Incident report

• •

SOP/Protocol/Report preparation ERP/LearnerWeb/QS Programs

PROFESSIONAL EXPERIENCE:

NESHER PHARMACEUTICALS LLC (ZYDUS USA) - OPERATION MANAGER 2012 -

2013

SECTOR: PHARMACEUTICAL -( CLASS 2 CONTROLL SUBSTANCE MANUFACTURING ) ST.

LOUIS, MO

• Direct all facets of operations at a production facility for this manufacturer of generic pharmaceuticals, ensuring strict compliance

with all corporate and regulatory requirements governing quality, safety, and scheduling

• Exercise supervisory authority over a team of two supervisors and 20 employees; boosted productivity by 200% through

production plans that achieved buy-in and consensus across all departments

• Assisted the launch of new products, leading technical support during QBD work to bring products to market that were free of

defects and in alignment with corporate and consumer expectations of quality

• Effectively managed the installation of 15 new pieces of equipment, validating new products without issue

• Coordinated and led classroom and on-the-job cross-training, empowering 20 operators to function in different disciplines to meet

the dynamic and changing needs of the production environment

• Cultivated a positive work environment that motivated each individual to achieve consistently higher levels of efficiency,

productivity, and operational excellence; reduced manufacturing incidents by 50%, and documentation errors by 50%

• Developed and deployed continuous improvement strategies to boost productivity while controlling costs, remaining within 95% of

the forecasted budget

• Led a full spectrum of corporate finance functions, including budget development and administration, and forecasts

• Observed strict compliance with all DEA regulations concerning the production of controlled substances

• Led efforts to ensure that all equipment was in proper working condition, validating processes, cleaning, and qualification

• Passed an FDA inspection without any violations

CARACO PHARMACEUTICAL LABORATORIES LTD 2004 - 2012

SECTOR: PHARMACEUTICAL (SUN PHARMACEUTICAL REVENUE : $1.3 BILLION)

DETROIT, MI

• Achieved a demonstrated record of success at this leading generic pharmaceutical company, marked by a series of promotions to

positions of increased influence, authority, and accountability

MANAGER OF MANUFACTURING (2008 - 2012)

• As Manager of Manufacturing, led vision, strategy, and execution of multi-shift department operations to ensure the timely and

accurate production of tablets, meeting all quality and safety standards

• Effectively managed a team of 6 direct reports, with dotted line accountability for over 25 operators. Served as the primary point

of contact during the course of FDA audits, working closely with FDA inspectors

• Shepherded new products from R&D to the Production shop floor, taking a lead role reviewing and approving manufacturing

protocols and reports, production and cleaning processes, and equipment; provided input at New Products Launch Management

meetings regarding technical details, timelines, objectives, and progress of deployment

• Introduced wide-ranging improvements through the Corrective and Preventive Action (CAPA) program

• Served as a trusted advisor to management with respect to the review, selection, and purchase of large-scale capital equipment used

in the manufacturing process; maintained a readily available inventory of spare components to ensure minimal impact to

production due to mechanical failures

• Worked with a consultant to develop and publish training documents to ensure consistency and compliance with Best Practices

throughout the manufacturing department

ASSISTANT MANAGER OF MANUFACTURING (2006 - 2008)

• Led the multi-shift granulation and compression department, overseeing 6 direct reports and 80 operators and ensuring the

effectiveness of corrective action activities. Managed the development of standard operating procedures to drive consistency and

higher safety ratings

• Planned daily, weekly, and monthly formulation activities in accordance with a strict production schedule, meeting all deadlines

and averting losses due to production delays

• Contributed additional service and expertise as the department Safety Coordinator, engaging in safety meetings, inspections of

equipment and plant, training, and safety function monitoring

• Collaborated extensively with engineers and product development personnel to address and resolve issues affecting the

performance of machinery and processes

• Achieved a 15% per annum increase in the production of solid dosage form in a cGMP environment for 3 successive years

• Successfully completed technology transfer operations of more than 20 products in co-ordination with the Research and

Development Department and Technical Services Department

SENIOR SUPERVISOR OF MANUFACTURING (2004 - 2006)

• As Senior Supervisor of Manufacturing, managed 2 supervisors, a section lead, and 30 operators in the execution of daily

manufacturing of pharmaceutical products

• Maintained accountability for a variety of human resources functions, including employee evaluations, promotions, and

performance management

• Identify process deviations to drive the development of corrective and preventative strategies

WOCKHARDT LIMITED, DAMAN - SENIOR EXECUTIVE FOR MANUFACTURING 2002 -

2003

SECTOR: PHARMACEUTICAL (REVENUE : $740 MILLION) GUJARAT,

INDIA

• Led a $10MM plant production operation for this leading pharmaceutical and biotechnology company headquartered in Mumbai,

introducing innovative improvement strategies to reduce costs and boost productivity

• Oversaw the actions of 4 direct reports and 20 employees in a multi-shift granulation department. Served as the custodian of all

necessary documentation, including Work Orders and Validation documents

• Consistently met or surpassed all monthly production targets, through the management of production planning responsibilities

• Successfully reduced the consumption of packing materials as well as the manpower cost per unit

• Achieved a 90% efficiency rate on the blister pack machine and compression machine

• Led training to 50 employees in the formulation plant, covering technical details, GMP rules, and documentation procedures

KAMRON LABORATORIES - PRODUCTION EXECUTIVE /PRODUCTION MANAGER 1994 –

1996/ 1999 - 2002

SECTOR: PHARMACEUTICAL GANDHINAGAR,

INDIA

• Managed total production activity of solid oral and aseptic, personal activity, excise dept., production- planning control

• Trained roughly 100 persons of middle and shop floors persons by training program on the G.M.P. and latest technology

• Conducted W.H.O. VISIT with W.H.O. team from Geneva

ZENITH HEALTHCARE - PRODUCTION MANAGER 1996 – 1999

SECTOR: PHARMACEUTICAL AHMEDABAD,

INDIA

• Managed total production activity of solid oral, personal activity, excise dept., production- planning control

TORRENT PHARMACEUTICAL LABS LTD - SENIOR CHEMIST 1991 -

1994

SECTOR: PHARMACEUTICAL GUJARAT, INDIA

• Production Supervisor responsible for overseeing tablet manufacturing activities (granulation, compression, coating) as well as

operator training, troubleshooting, and the creation of BMRs and SOPs

EDUCATION:

• GUJARAT UNIVERSITY/LM COLLEGE OF PHARMACY – Gujarat, INDIA

Bachelor Degree in Pharmacy - 1987 - 1991

TRAINING:

• Certified Lean Six Sigma Green Belt – Villanova University

• Conducting Bulletproof CAPA Investigations

• (MI)OSHA 10 hour Safety Course

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