Carlos Malabay Cammayo
Independent Pharmaceutical Quality and Compliance Consultant
Senior Quality and Compliance Professional with four decades of extensive experience in manufacturing, quality assurance, quality auditing, R&D, contractor management, supply and distribution of pharmaceutical and consumer healthcare products. My pharmaceutical industry experience is mostly from the multinational environment including GlaxoSmithKline Ltd. Pte (Singapore), Reckitt Benckiser Thailand, GlaxoSmithKline Philippines, SmithKline Philippines, Sterling Drug Philippines and Pfizer Philippines.
I started my career in the pharmaceutical manufacturing industry at United Laboratories Inc., the biggest national pharmaceutical manufacturer in the Philippines, where I was a Researcher at the Pharmaceutical Research and Manufacturing Development Division and ended my full time career with the same company as Division VP of Corporate Quality Assurance and Compliance.
Qualification Highlights
- Technical experience (Philippines [38+ years], Singapore [4 years], Thailand [2 years]): Quality Assurance and Compliance (Change Control, Complaints & Product Incident Management, Root Cause Analysis, Corrective and Preventive Action Management, Quality Risk Management); Quality Auditing (Internal, Contractors, and Suppliers); Manufacturing Technology & Product Transfer (New Product Introduction/Development); Manufacturing Operations; Regulatory Affairs and Compliance; Technical Services (Product, Process & Plant Utilities Validation); Management of Contract Manufacturer and Service Provider impacting Product Quality; Vaccines Cold Chain Management.
- Expert in technical project management of product, process and technology transfer to support the timely product registration, production and launch of new products/innovations in plant and in contract manufacturing sites.
- Experienced in leading the implementation of quality management system (QMS) in: manufacturing operations; commercial organization; and 3rd party service providers (Distributor, Warehousing & Storage providers, Contract Manufacturer and Repacker, Artwork studio and Printers of products’ packaging materials)
- Experienced in performing compliance audits of manufacturing and quality operations of: manufacturing sites; raw and packaging material suppliers; warehousing, storage and distribution providers using internal quality standards, GMPs (PIC/S), GDP, GWP, GSP.
- Broad product range manufacturing experience in different pharmaceutical dosage forms
I started my career in the pharmaceutical manufacturing industry at United Laboratories Inc., the biggest national pharmaceutical manufacturer in the Philippines, where I was a Researcher at the Pharmaceutical Research and Manufacturing Development Division and ended my full time career with the same company as Division VP of Corporate Quality Assurance and Compliance.
Qualification Highlights
- Technical experience (Philippines [38+ years], Singapore [4 years], Thailand [2 years]): Quality Assurance and Compliance (Change Control, Complaints & Product Incident Management, Root Cause Analysis, Corrective and Preventive Action Management, Quality Risk Management); Quality Auditing (Internal, Contractors, and Suppliers); Manufacturing Technology & Product Transfer (New Product Introduction/Development); Manufacturing Operations; Regulatory Affairs and Compliance; Technical Services (Product, Process & Plant Utilities Validation); Management of Contract Manufacturer and Service Provider impacting Product Quality; Vaccines Cold Chain Management.
- Expert in technical project management of product, process and technology transfer to support the timely product registration, production and launch of new products/innovations in plant and in contract manufacturing sites.
- Experienced in leading the implementation of quality management system (QMS) in: manufacturing operations; commercial organization; and 3rd party service providers (Distributor, Warehousing & Storage providers, Contract Manufacturer and Repacker, Artwork studio and Printers of products’ packaging materials)
- Experienced in performing compliance audits of manufacturing and quality operations of: manufacturing sites; raw and packaging material suppliers; warehousing, storage and distribution providers using internal quality standards, GMPs (PIC/S), GDP, GWP, GSP.
- Broad product range manufacturing experience in different pharmaceutical dosage forms