Jignesh P. Khamar

Somerset, NJ *****

ad37wm@r.postjobfree.com

Cell: 732-***-****

PROFESSINAL SUMMARY:

Worked in pharmaceutical Companies like Aurobindo Pharmaceuticals, Sun Pharmaceuticals, Sunrise Pharmaceutical etc. in Quality Assurance, manufacturing, Packaging, and labeling control in cGMP environment.

Performs quality inspections, checks, and tests during the manufacture of products. Inspects materials, parts, and products at different stages of production. Records Observations and may make recommendations for improving processes.

Training Q.A. Inspectors for in-process checks, as per the compliance.

Issue the Batch Records, and Annual Product Review of the Finished product.

Familiar with cGMP, documentation, and pharmaceutical practices.

Review the Batch Records. Incoming Raw material and Packaging components Sampling.

PROFESSIONAL EXPERIENCE:

SUNRISE PHARMACEUTICAL. NJ

Position: Quality Assurance Lead/Supervisor Operations. Feb2016-Nov.2023

Assuring the purity, integrity, and quality of pharmaceutical products.

Enforcing cGMP guidelines for manufacturing and packaging of pharmaceutical products.

Coordinate and direct daily routine activities to all QA inspectors on the floor.

Troubleshoot and provide solutions/suggestions for any problems or issues that arise during routine quality related tasks.

Coordinate with other departments to provide support as a quality perspective to get production out of door smoothly, without deviating from any procedures or guidelines.

Perform Inspection and sampling on all incoming raw materials, packaging components and returned goods following detailed written procedures.

Perform Labeling component receipt, visual examination, counting, preliminary inspection and sampling.

Visual inspection and preparation of report of all products for APR

Rejection of retain samples upon their due date of storage period.

Adhere to compliance of Warehouse area in terms of Isolation of Quarantine, Released, In-Process, Finished Product, Packaged Product, Returned Goods, and Rejected areas.

Ensure the proper isolation of rejected material generated during batch process and accountability in the batch record.

Identifying any deviations and report to upper management SUN PHARMACEUTICALS, NJ

Position: Quality Assurance Inspector Nov 2015-Feb 2016

Support activities for incoming inspections

In-process checks for packaging and for manufacturing

Perform area assessments and ensures compliance with SOP’s, Policies, and Procedures.

Leverage on-the-floor presence to proactively identify opportunities and provide coaching.

Execute the final release inspections of packaging lines. AUROBINDO PHARMACEUTICALS, NJ Nov 2014- Nov 2015

Position: Compression Operator 2014-2015

Responsible for compression machine (tablet press) operation, set-up, and maintenance

Operated tablet press machinery independently as well as within a team environment

Matched all labels with batch records.

Responsible for loading and unloading tablet press machine.

Monitored tablet press operation periodically and reports any abnormal conditions to the manager.

Performed tablet test-Hardness, dissolution, dimensions for quality of products.

Machine operated- Tablet press SEJONG-36 AND SEJONG-49D (TWO STATION) Compression Machine

Complies with company policies and procedures.

Personal responsibility for following safety rules, SOPs, and cGMP guidelines Position: Line Lead Aug 2010- Nov 2014

Leading the team of 7 employees

Responsible for the packaging line operation, set up and maintenance.

Responsible for document for hourly in process quality checks

Responsible for packaging material check, verification as per batch record

Batch finishing reconciliation and report

Responsible for line clearance process

Training to new employee for machine operations, cGMP, SOPs EDUCATION:

Bachelor's degree, Electrical Engineering & Production Management, Gujarat University

CERTIFICATIONS:

Project Management Foundations

Quality Management Foundations

Six Sigma: Green Belt

SAP ERP Essential Training

Quality Management for Operational Excellence

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