CHIRAG B. PATEL

** ******** **. **** *******, NJ-08520. Cell Phone: 1-551-***-**** Email : ad0qaa@r.postjobfree.com PROFESSIONAL SUMMARY:

A dynamic professional 20+ years of pharmaceutical experience in packaging validation and operation of solid oral dosages, liquid, and parenteral dosage forms.

Extensive experience in Packaging process validation, Labeling control, Serialization, Validation, Enterprise Resource Planning (ERP), SAP, Technology transfer, Market complaints, Manpower management and Supply chain.

Strong in time management and prioritization, compliance, quality, efficiency, productivity, decision making, technical skills, project management, regulatory, continuous process improvement, reducing the down time, leadership, training, team building and communication fields. PROFESSIONAL EXPERIENCE:

KVK Tech. Inc. Newtown, Pennsylvania, USA (Sep 2020 – Present) Senior Manager Packaging

Manage day to day operations of packaging department.

In charge of daily planning and scheduling to ensure proper workflow.

Remediated warning letter/483 observations related to packaging department through gap assessment.

Monitor, organize and execute all functions associated with packaging of pharmaceutical commercial products and ensuring compliance with cGMP, SOP, FDA, DEA and OSHA rules and regulations.

Accountability of manpower utilization, departmental discipline, maximum utilization of the available resources, online job training to workers and subordinates based on SOPs and evaluation.

Work directly with senior management and group leaders to ensure appropriate follow through of the weekly planning schedule.

Prepare and review packaging documents. (i.e Deviation, CAPA, Protocol, Report, PMR, SOPs etc.)

Coordinate with QA and warehouse personnel to ensure availability of required materials.

Motivate a diverse workforce of all employees to exceed department goals, which includes safety, quality, and productivity.

Work with HR department related to staffing hiring process and any issues.

Attend packaging and production meeting in a timely manner.

Handle and complete special projects as required.

Plant modification to enhance plant capacity by implementation of innovative system and techniques. OHM LABORATORIES INC. (a SUN PHARMA COMPANY) New Brunswick, New Jersey, USA Senior Packaging Engineer – Packaging (May 2019 – Sep 2020)

Manage complete packaging development process.

Creation of packaging designs, prototype development, performance testing, flawless launch execution with both internal operations and external suppliers.

New and existing packaging problems, troubleshoot, designs, material, process and provide creative, timely and cost-effective solutions.

Review engineering drawing and specifications of product to determine physical characteristics of item and types of materials required for packaging.

Implement cost-saving initiatives related to packaging materials, labor, efficiency, transportation, and storage.

Prepare Packaging validation documents, CCRs, PBRs, BOMs, SOPs, protocol, and report.

Execution characterization, Validation, Exhibit batches, CAPA and investigation.

Provide support during audits and support audit observation closer.

Ensure all products are packaged according to Quality standards during execution and review of packaging documents.

SUN PHARMACEUTICAL IND. INC. Cranbury, New Jersey, USA (July 2014 – May 2019) Sr. Scientist – Manufacturing, Science and Technical Group (MSTG)

Writing the process validation/verification protocol and report for packaging process inline with the current FDA process validation guideline.

Preparation of user friendly BPR (Batch Packaging record) for Commercial, Exhibit and Intended.

Preparation and execution of Process characterization/Engineering Studies, Verification, Validation, Cleaning Validation, Stability, Exhibit and Commercial batches, Shipping studies protocols and reports.

Outstanding understanding of Packaging validation principles.

Handling of system change control, investigation, planned events and Implementation & monitoring of effective CAPA through Trackwise system.

Always maintained cGMP standards for regulatory compliance.

Focused on solving technical problems, improving productivity with high compliance requirement.

Production planning and conducted daily planning meeting, analyzed packaging issues, and resolved in timely manner.

Knowledge of Consumer Product Safety Commission (CPSC), 16 CFR 1700.15 (Poison prevention packaging standards) and General Certificate of Conformity (GCC).

Prepared bill of material (BOM) in ERP/SAP for packaging of Exhibit and commercial batches.

Coordinate with Regulatory department for artwork development process, new SKU development, commercial launches, and routine artwork changes.

CARACO PHARMACEUTICAL INC. LTD. Detroit, Michigan, USA (May 2010 - July 2014) Sr. Supervisor Packaging

Plan shift work and operations on packaging lines as per production requirement and meet daily and monthly production targets. Coordinate with external departments to meet micro schedule.

Complete documentation in a timely manner including the review BPRs and writing of SOPs, Protocols (IQ, OQ and PQ), Reports, incident, investigation, CAPA and Market complaint.

Directly contribute to Packaging Validation. Engineering Studies and qualifications of packaging equipment and lines.

Improve packaging efficiencies by changing work methods, reducing set-up times, and identifying improvements to equipment. Reduced equipment and system downtime with adequate parts inventory and efficient preventative maintenance. Troubleshoot various issues relating packaging processes

Additional responsibility for Transdermal products activities like coating, slitting, Die-cutting, Pouching and Packaging of pouches.

Preparation of department daily & monthly reports along with plant monthly WIP. Monitor receipt, release, availability, consumption, inventory history record and reconciliation of packaging materials.

Establish, maintain, and continually analyze packaging, control, and documentation procedures to assure departmental compliance with current Good Manufacturing Practices, improve yields or reduce cost with proper manpower utilizations.

Develop, train, and motivate operators to maximize job performance through skill development, employee education and assessment.

SUN PHARMACEUTICAL INDUSTRIES. LTD. Halol, Gujrat, India (October 2002 – May 2010) Sr. Executive Packaging

Planned monthly production based on RFC (Rolling Fore Cast).

Supervise and controlled day to day production activity to meet delivery schedule.

Assisted officer/supervisor in controlling the functions related packing activities of ANDA (Abbreviated New Drugs Application) Exhibit batches, Domestic and Export (i.e. Tablets Capsules, Injectable and Aerosol product).

Planned shift schedule and manpower usage to result in maximum output and productivity from all equipment and personnel in a team environment.

Developed packing materials/change parts for new products (NDA/ANDA).

Procured change parts and miscellaneous items for day to day use and machine maintenance.

Improved production and inventory control system, to improve quality, cost saving and maximize production management.

Used technical knowledge of:

Bottle Packaging line. (Slat counter, Countec, Ace-packer, Koma-Count etc.)

Blister Pack machine. (Alu/Alu, Alu/PVC), Strip pack machine, Cartoning Machine etc.

Worked with documentation like the following:

BPR (Batch Packaging record) for Domestic, Export and ANDA (Exhibit, Intended and Commercial), SOP, Equipment / Area Protocol (URS, FAT, SAT, IQ, OQ, PQ), Process / Verification / cleaning validation Protocol/report.

Monthly / Quarterly report and Yearly Budget.

ELYSIUM PHARMACEUTICAL LTD. Padra, Gujarat, India (August 2001 – September 2002) Packaging Supervisor

Planned shift work and operations on packaging line as per production requirements and supervised the Packaging Operation on daily basis.

Completed BPR on daily basis.

Met daily production targets.

Kept online documents in compliance with current Good Manufacturing Practices.

Increased yields and reduced costs.

EDUCATION:

GUJARAT UNIVERSITY, Waghodia, Gujarat, India. Bachelor of Science (Chemistry) ADDITIONAL SKILLS:

Demonstrated interpersonal, organizational, Strong teamwork, fast learner, time management skills and leadership qualities.

Quality and productivity improvements, strong technical aptitude in solid oral dosage Packaging.

Troubleshooting of complex Packaging process related problems and make sound decision that support company goals.

Exceptional knowledge of all pharmaceutical’s rules and standards and Proficient in Microsoft Office.

Change part, Packaging Material & artwork development, Process development and validation.

Continuous Improvement and Cost Saving

Adept in resolving technical issues through root cause analysis and providing technical support to internal customers.

(Chirag B. Patel)

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