Robert Foster

Global Quality Leader Mfa Api Platform @Phibro Animal Health

Belmont, WV, US
EMAILS
r••••••••@pahc.com
MOBILE NUMBERS
+19•••••••67

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WORK HISTORY

Nov 2024 — Present

Global Quality Leader Mfa Api Platform @Phibro Animal Health

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Global Quality Operations for sites in EU, China, and USA

SKILLS

Analytical ChemistryContract ManufacturingCROComplianceGxpQuality AuditingAseptic ProcessingDesign ControlRoot Cause AnalysisChange ControlIch Guidelines21 Cfr Part 11GlpUspDeviationsDrug DeliverySop DevelopmentSterilizationRegulatory AffairsCleaning ValidationComputer System ValidationDrug DevelopmentQuality by DesignQuality AssurancePharmacovigilanceHplcQuality ControlGmpRegulatory SubmissionsProtocolPharmaceutical IndustrySopDeviation ManagementFdaCgmp PracticesDissolutionQuality SystemNdaPharmaceutical ManufacturingFormulation

ABOUT ROBERT FOSTER

An expert in quality and compliance for the pharmaceutical and related industries. Experience includes leadership in Pharmaceutical, Generic, OTC, Medical Device, and Cosmetic production sites with emphasis in; sterile ophthalmic, topical creams and ointments, non-sterile oral liquids/suspensions, IV products, and exceptional experience/expertise with solid oral dosage forms. A business integration leader for product acquisition, divestment, and development. Training includes certification requirements for EU QP role & responsibilities. Completed remediation and establishment of quality/compliance systems for firms with a FDA Warning Letter. This enabled the firms to achieve a normal compliance status with the FDA and obtain PAI\'s and ANDA approvals. Excellent cGMP, ISO, and R&D Compliance Auditor.A leader who has developed and established effective teams/organizations. A leader that enjoys teaching, mentoring, compliance into teams and organizational cultures.Experiences include working with industry groups and FDA/USP task group committees to establish and edit regulations and monographs. Expertise in working with and building relationships with Contract Service Providers. A drug product stability programs, statistical data evaluation, technical report writing, and formulation investigations expert. Quality investigation techniques and writing style have been incorporated into corporate policies and have received very positive commentary from FDA Investigators and client auditors.Adept at developing, and sustaining best in class cost effective supplier quality management systems. I may be reached at f••••••••@yahoo.com or by calling (97••••••67, I am located in the Eastern Standard Time zone.

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