Vipulkumar Patel Email & Phone Number

Ramsey, NJ

Oversee day to day operations of the Quality Control Laboratory, Qualification and Development and Validation Departments while ensuring adherence to cGMP’s and CGLP’s and safety requirements and provide senior technical leadership in Quality Control to enable the development, validation, and optimization of analytical methods in support of both internal.

Whippany, New Jersey, United States

• Served as head of QC, managing QC lab. Facilitated operations by supporting production, raw materials, and finished product releases as well as stability testing for Commercial and Clinical and managing Microbiology.
• Managed over 35 individuals in QC laboratory (including five direct report managers).
• Facilitated project management efforts, including working with clients and vendors, handling laboratory compliance, overseeing FDA and client audits, developing responses to observations, and promoting safety awareness.
• Led daily hurdle (Tier 1) morning staff meetings.
• Oversaw laboratory investigations (i.e., OOS, OOT, OOC, and lab deviations), using Track Wise.
• Conducted daily production / supply chain meetings (Tier 2) as well as updates.

East Brunswick, NJ

• Acted as key regulatory compliance liaison to interface with regulatory agencies during audits of lab operations. Handled US FDA inspections, including audits conducted by outside consultants and customers.
• Directed and prioritized quality control and analytical method validation. Supervised and managed 50 individuals in the QC laboratory (including five direct reports).
• Reviewed and approved laboratory documents, including SOPs, change control, investigations, planned events and deviations, ANDA submissions, deficiency responses, and environmental monitoring program.
• Established policy and adherence to FDA data integrity and compliance with drug cGMP.
• Participated in QMS and MRMs to track and monitor the progress of quality metrics and compliance.
• Led establishment of raw material, in-process and finished product, and stability specifications as well as expiration dating on commercial products to ensure regulatory compliance.

East Brunswick, NJ

Greater Detroit Area

• Directed and prioritized primary activities for quality control and analytical method validation.
• Managed 70-plus individuals in the QC laboratory (including five direct report managers).

Greater Detroit Area

Greater Detroit Area

Greater Detroit Area

Toronto, Canada Area

Vadodara Area, India

Vadodara Area, India

Vadodara Area, India

Medicinal Chemistry, Ms Organic Chemistry (Drugs)

Bs Chemistry