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GMDP-0046

Independant Consultant - Oral Solid Dose Expert & Global Operations Leader

Available
27
Years Experience
Process Engineering
Specialization
Ireland
Location
About This 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.

Competencies

Expert
Process validation Liquid & semi-solid Oral solid dosage
Advanced
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
Intermediate
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)
Request Information

Interested in this expert? Fill in the form below to start the process. For €50, you'll receive a detailed anonymized CV. If you'd like to proceed to a personal introduction, that's €1000.