Brandon Kolar
- Role
- Associate Director, Quality Compliance at Osmotica Pharmaceutical Corp
- Location
- Marietta, GA, US
- LinkedIn followers
- 500 followers
About Brandon Kolar
I have worked in the pharmaceutical industry since 2003, primarily for solid dosage…
Experience
Associate Director, Quality Compliance
Dec 2021 — Present
Manage team of quality associates including Quality Inspection Supervisor, Quality Specialists, and Document Control across two sites. • Maintain a document management system for the control and accessibility of GMP documents (e.g, protocols, specifications, and production records). Manage onsite and offsite storage solutions, ensuring timely and accurate retrieval mechanisms. • Provide quality oversight for GMP laboratory activities • Provide quality oversight for production and packaging operations • Facilitate production floor inspections, incoming material inspections, room releases, and AQL testing • Determine the acceptability of laboratory procedures and activities • Approve or reject laboratory documents including SOPs, specifications, change controls, investigations, deviations, CAPA, protocols, reports, and other related documents • Participate in improvement of laboratory processes to ensure quality and adherence to cGMPs • Conduct, review, and/or approve 21 CFR Part 11 assessments on new and existing computerized systems and GMP software/vendors: review and disposition periodic re-qualification assessments • Develop and manage quality metrics to provide a status of laboratory and quality system activities • Provide laboratory compliance expertise in external laboratory issues (e.g, CMOs, contract labs) • Manage quality agreements with site suppliers • Maintain USP water system results and perform trending for site leadership • Recommend opportunities for increased quality system efficiencies and operational improvement through modifications to current systems and implementation of new systems • Approve or reject product stability protocols • Approve or reject site work orders, calibration reports, and equipment qualification documents • Approve or reject site deviations, non-conformance reports, change controls, batch records, protocols, procedures, and policies • Support FDA and 3rd party inspections, and maintain site readiness for inspections
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