Mark Barr Email & Phone Number

Blountville, TN, US

Helping pharmaceutical companies with anything related to Quality. I have developed and implemented quality processes & SOPs for multiple companies, reviewed Quality issues and recommended strategies, reviewed investigations, reports, executed batch records, etc. Performed audits & PAI gap analyses.

Bridgewater, NJ, US

Responsible for all aspects of Quality for Osmotica Pharmaceuticals plc which also includes Vertical Pharmaceuticals, Trigen Laboratories and RVL Pharmaceuticals.

Hyderabad, TS, IN

Responsibility for all Quality aspects at the site manufacturing solid dosage products

Huntsville, AL, US

Responsible for all Quality operations for a solid dosage manufacturing and packaging facility. My Quality group totalled about 140 people in QA and QC.

New York, New York, US

Pfizer acquired King in January 2011.

Bristol, TN, US

Site Head of Quality for both Bristol and St. Petersburg manufacturing facilities that manufacture and package tablets, capsules, creams and ointments. Responsible for all aspects of Quality Assurance and Quality Control laboratories. Currently have 60 people that report through me.

Bristol, TN, US

Direct the activities of the quality assurance group that includes incoming materialssampling and release, bulk product inspection and release, finished product inspection and release for the Bristol and St. Petersburg sites. Also responsible for the quality oversight of the 33 product lines that are contract manufactured for King Pharmaceuticals. Had 24.

Bristol, TN, US

Directed the stability group that is responsible for the overall stability program including all stability testing. Managed the laboratory metrology group that is responsible for all laboratory calibrations, maintenance and instrument repairs.

Bristol, TN, US

Managed all aspects of the corporate LIMS (Laboratory Information Management System) and corporate CDS (Chromatography Data System) projects. Obtained expenditure approvals and reported progress to a Corporate Steering Committee chaired by the CEO.

Bristol, TN, US

Responsible for all aspects of the Scientific Development laboratory including analytical method development and validation, process validation testing and method qualification testing. Was the lead person for the Scientific Development department during FDA inspections. The Scientific Development department was disbanded in December 2010. Had 11 people.

Bristol, TN, US

Responsible for all aspects of the Scientific Development laboratory including analytical method development and validation, process validation testing, method qualification, and stability testing for product development. Heavily involved in laboratory functions related to SUPAC transfers.

Bristol, TN, US

Supervised development chemists performing analytical method development and validation. Wrote process validation protocols and summaries, analytical procedures and method validation summaries. Developed responses to FDA deficiency letters to ANDA submissions and interacted with FDA inspectors during pre- and post-approval inspections. Heavily involved in.

Supervised development chemists performing analytical development and validation, finished product stability testing, pilot batch testing and process validation testing. Wrote process validation protocols, process validation summaries, analytical procedures, method validation summaries and finished product stability reports.

Developed and validated analytical methods for a variety of pharmaceutical products by HPLC, GC, UV, AA, IR, and wet chemistry. Performed stability, process validation, and cleaning validation testing.