Hirenkumar Patel Email & Phone Number

Bridgewater, Nj, Us

New Jersey, United States

Princeton, New Jersey

United States

Currently, Working for drug delivery, development and specialty pharmaceutical company. Responsible for the management of all company cGMP systems, regulatory compliance, document control, stability programs, and raw materials/finished product release.Responsible for the oversight, reporting and monitoring of company's quality systems, including investigations, corrective actions (CAPA), training programs.Responsible for the improvement of existing systems and the development of new quality systems.Audits: Perform internal and external (Vendor/Facilities) auditsWork with customers to resolve quality related issues.Define training matrix requirements for job functions.Monitor compliance to reduce training gaps.Review and approve SOPs and SOP revisions.Create new SOP's with respective department as per business needs.Notify Quality Management of any issues and interface with all levels of Kashiv team to resolve issues.Perform other job-related duties as assigned.

New Jersey

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Ridgefield Park, New Jersey

• Participated in various change control projects for secondary packaging components and presented to higher management.• Comply with SOP’s and cGMPs while packaging and inspection in the most efficient and safest way.• Qualified and certified inspector of filled product.• Manual Visual Inspection of Sterile filled containers like Vial or pre-filled syringes • Review batch records and applicable documents for compliance and accuracy.• Use MRP system to enter work orders and access batch information.• Ensure training is up to date with all Quality assurance employees.• Collaborate with planning, warehouse, and other departments to ensure prompt production.• Follows standardized procedures (SOPs) under close supervision by lead operators in performing assigned unit operations necessary to support production.• Performed routine tasks in the areas of packaging, warehouse, and equipment preparation.• Maintained all associated documentation for operations being performed on batch record. • Serve as witness of routine unit operation tasks for batch record signing.• Receives detailed instructions on all work through written procedures or by supervisor

Ahmedabad Area, India

• Performing room, line clearance, and in-process checks for the manufacturing and packaging areas according to applicable SOPs.• Sampling and inspecting raw materials, components, labeling and finished products according to current standards.• Inspecting raw materials, in- process, bulk and finished products throughout the manufacturing cycle to determine compliance with all controlled documentation that contains product specifications according to SOPs. These documents include, but are not limited to, manufacturing batch records, packaging batch records and validation protocols.• Submitting raw material, in-process and finished product samples to the QC lab for chemical testing as indicated by department procedures.• Performing final reconciliation audits of manufacturing and packaging batch records.• Participating in any investigation for deviations from the batch record.• Assisting in the review and writing of applicable SOPs when needed.

Master'S Degree, Health/Health Care Administration/Management, A

Master'S Degree, Pharmaceutical Manufacturing

Bachelor'S Degree, Pharmacy