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GMDP-0046

Independant Consultant - Oral Solid Dose Expert & Global Operations Leader

Disponible
27
Années d'expérience
Process Engineering
Spécialisation
Irlande
Localisation
À propos de cet expert

A highly motivated graduate with in excess of 25 years’ technical and global operations management experience in Oral Solid Dose, Sterile and Sterile Drug Product Manufacturing and Packaging, from the clinical stage through to variety of roles within Corporate, R&D, New Product Introduction, Commercial Manufacturing and CDMO management. Skill set is developed from technical and operations leadership in medium to large pharma, with overall accountability for the continued supply of quality product to market, including supply chain, regulatory and quality assurance management in a matrix team environment. Have extensive hands on and theoretical knowledge, including management of CMC changes, product transfers and complex changes to regulatory submissions. Experienced manager of both direct reports and matrix teams. Regularly utilize ISPE and RAPS to further increase/maintain industry knowledge. Green belt lean six sigma certified.

Compétences

Expert
Process validation Liquid & semi-solid Oral solid dosage
Avancé
Annual Product Quality Review Deviation Management Cleaning validation Packaging Change Control CAPA Management SOP Writing & Review Out-of-Specification (OOS) Investigation IQ/OQ/PQ Validation Equipment qualification Regulatory inspection support Regulatory Submissions
Intermédiaire
Stability Study Design & Execution Internal auditing Analytical testing Supplier Auditing Computer system validation GMP Auditing Method validation

Certifications

RAPS Dual Certification – Regulatory Affairs Lean Six Sigma Green Belt BJCP Certified Beer Judge RAPS dual Certificate: Pharmaceuticals & Medical Devices CMC (2024-09-03) Six Sigma (2013-07-27)
Demander des informations

Intéressé par cet expert ? Remplissez le formulaire ci-dessous pour démarrer le processus. For €50, you'll receive a detailed anonymized CV. If you'd like to proceed to a personal introduction, that's €1000.