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Supervisor/Manager of people, production.

Location:
Irvine, California, United States
Posted:
January 20, 2018

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SHASHWAT MISHRA

*** ******, ******, ** *****

(714)***-****

ac3383@r.postjobfree.com

OBJECTIVE

Industry Professional with over 20 years of cGMP Pharmaceutical and Medical Device Manufacturing & Packaging experience in Sterile and Non-sterile Solids, Semi-solids and Liquids, seeking opportunity to contribute to your organization in a professional role.

SKILLS AND EXPERIENCE SUMMARY

Proven success in production supervision, production management, packaging production, quality and process excellence with advanced education in the field of pharmacy and pharmaceutical business. Safety-focused leader in Right First Time (RFT) initiatives & Continuous Improvements. Skilled in production planning, purchasing, scheduling, inventory management. Knowledge of supply chain management, ERP, MRP systems. Experienced participant in cross-functional teams. Proficient in writing procedures, protocols, and reports. Knowledge of Microsoft Outlook, Word, Excel, PowerPoint, Minitab and SharePoint.

WORK EXPERIENCE - PHARMACEUTICAL INDUSTRY

SHIRE / BAXALTA, LOS ANGELES, CA 2016-2017

Sr. Supervisor, Ramp up - Pharma Manufacturing

Hired and Supervised technicians and MA's. Assisted Start up and Ramp up project teams.

Lead PPQ (Conformance lots). Safety champion for all departments. Created new procedures and forms. Assisted in 5S of all departments. Delta V and Electronic Batch Management (EBM) experience

Performed safety and compliance inspections

Worked with several vendors. Assisted design/order of new equipment's, storage carts.

JOHNSON & JOHNSON / PFIZER INC. 1997-2015

Sr. Team Leader, Compounding

Supervise 30 compounders, sanitechs, pre-weigh, temporary workers.

Consumer healthcare / OTC - Hair and Skincare products, Ointments, Creams, Lotions, and Soaps.

Review MWI’s, CWI’s, and Logbooks. Write safety related Incident reports. Assist in the Batch Record Review corrections. Report Quality Investigations (INV’s). ETQ Reliance. Suggest safety improvements.

Performance Development Plans. Make 2 Win Team. Compliance Wire.

Engineer / Technical Services Specialist, Sterile Operations 2006-2008

Managed Process Engineers responsible for Production & Packaging of solids, semi-solids & liquids. OTC products, Ophthalmics - Eye Drops, Ointments, Creams, Lotions, Syrups.

Authored Quality Assurance Investigations (QARs), implemented defined CAPAs. Lead Make2Win Teams. Initiated process changes that saved $10+ million in operating costs.

Researched and interacted with multiple vendors to qualify filter bags.

Sr. Manufacturing & Packaging Supervisor, Sterile & Non-Sterile Operations 2004-2006

Experienced with TL filling lines, Nikka-Densok inspection machine, Krones labeler, Jones cartoner & Brenton case packer. Supervised shift leads & 150+ employees. Performance Development Plans for direct reports. Initiated process improvements that led to $2+ million in savings.

Sr. Manufacturing Supervisor, Compounding, Tableting, and Sterile Operations 2000-2004

Supervised 50+ employees and conducted Performance Reviews

Installed, Configured & Troubleshot Manesty Mark IV & Elite 800 Tablet Press

Experienced with Compression of Single and Double Layered Tablets, Sampling and Monitoring of Tablet Quality & Tablet Bulk Packing, Wet & Dry Granulation blending processes, H&K encapsulators, capsule inspection equipment (Vericap), and Operation and Qualification of PK processors, Fitz Mills, and other portable equipment.

Experienced with Sterilizers, Amsco (filled glass bottles) & Fin-Aqua (filling parts), Stelm (Rubber Stopper Washer), FM inspection (Esai), Fillmatic (filler) and Cozzoli (filler and bottle washer).

QA Supervisor 1997-2000

Conduct internal audits to ensure compliance with FDA regulations and internal procedures. Review and approve all deviation/investigation reports and ensure root causes and corrective actions are properly assigned and tracked to completion. Perform designated job duties of the Quality Manager in his absence.

Supervise QA Specialists to ensure completeness and accuracy of work in a timely manner to facilitate product release. Participate and coordinate customer and FDA audits covering all aspects of plant operations. Release finished product, prepare Certificates of Analysis, Compliance, and Testing and perform inspections for shipments. Prepare annual product reviews. Evaluate and qualify raw material manufacturers as part of the supplier approval procedure. Customer complaint management.

SYRUP THIOKOF MFG. CO., MUMBAI, INDIA 1992-1996

Manufacturing Manager

Promoted to Manager within 6 months. Managed 75+ employees and the first shift site operations.

EDUCATION

Certificate, Supply Chain Management - UC Irvine, CA (Present)

Certificate, Pharmaceutical Business, Honors, University of Sciences, Philadelphia, PA (2010)

BS, Pharmacy, Honors, P.E.S. College, Bangalore, India (1995)

TRAININGS AND COURSES

Lean Green Belt Training. Kaizen. Six Sigma Awareness. Introduction to Process Excellence Awareness.

Industrial Pharmacy, Graduate level 11 courses (33 credits) - LIU, Brooklyn, NY. Supply Chain Management course - CSU Dominguez Hills, CA (2017)

RECOGNITIONS AND AWARDS

Inspired Teams - Safety is No.1 priority; Always on top of things; Bravo. Passion for improving lives - Kudos. Flawless Quality. The Values Connection - Worked Overtime to finish rework; Customer Service; Teamwork; Performance. Living the Credo - Customer Service. Perfect Attendance. Maintains Accountability - Met the corporate deadline for timecards.



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