Donat Ambe

With enormous experiences across the pharmaceutical industry, I am currently supporting Innomar’s activities in my current role as Senior Quality Assurance Specialist in the following activities (but not limited to): On-boarding and managing of Third Party Logistics (3PL) activities for top Canadian and foreign pharmaceutical companies. Actively coordinating and collaborating with Importers of Record for receiving, sampling, inspecting and releasing pharmaceutical products into the Canadian market in compliance with Canadian GMP regulations. Providing support in inventory management, defect/damage investigations, transportation/storage temperature assessments, product return evaluations etc. Importer of Record support activities for Imported Drug/Biologics products, Natural Health products (NHPs) and Medical devices for release into Canadian market in accordance with Canadian GMP regulations. Batch records and batch certificates reviews, master production documents reviews, Annual Product Quality Reviews (APQRs), Stability review/trending, organizing Identity/annual confirmatory testings, UID verifications, product release, product recalls, temperature assessments, drug recalls, etc. Actively supporting pharmaceutical partner companies in GMP compliance through activities such as change management/change controls, deviations/investigations, CAPAs, audits, document reviews, QMS document updates. Management of narcotics and controlled drug substance activities such as receiving, storage (access control), order verification/picking, inventory control/verification and shipping. Develop and execute product protocols for inspection, labelling, relabelling, over-labelling and other rework projects. Leading team management activities such as on-boarding and training of new team members, organizing/hosting meetings and team activities, coordinating the day to day activities of the team towards optimization workflow an improving the overall team’s performance.

Product Quality & Compliance. Review batch documentation (Certificate of Analysis, Certificate of Compliance, and executed batch records) for completeness and compliance prior to local market release. Perform local Quality Release of finished products in accordance with Canadian regulatory requirements and internal SOPs. Ensure compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) as per Health Canada and corporate standards. Maintain and oversee the Canadian Drug Establishment Licence (DEL) activities, site updates and renewal submissions in coordination with Regulatory Affairs. Participate in internal and third-party audits and inspections; support CAPA implementation and follow-up. Review batch documentation (Certificate of Analysis, Certificate of Compliance, and executed batch records) for completeness and compliance prior to local market release. Perform local Quality Release of finished products as per Canadian regulatory requirements and internal SOPs. Ensure compliance with Good Manufacturing Practices (GMP)and Good Distribution Practices (GDP) as per Health Canada and corporate standards. Maintain and oversee the Canadian Drug Establishment Licence (DEL) activities, including site updates and renewal submissions in coordination with Regulatory Affairs. Participate in internal and third-party audits and inspections; support CAPA implementation and follow-up. Maintain Quality Management System (QMS) documents, including SOPs, change controls, deviations, CAPAs, and complaint records. Support supplier and contract manufacturer qualification/monitoring, including collection and review of Quality Agreements, audit reports, and technical documentation. Monitor temperature excursion reports and provide QA disposition. Prepare and maintain Annual Product Quality Reviews (APQRs) as applicable for Canadian market. Support readiness and documentation for Health Canada inspections and related pre/post-inspection communications

• In-depth knowledge and understanding and application of HPFB and FDA regulations (cGMP and GMP) and ICH guidelines.  • Technical writing (SOP, work instructions, protocols, control sheets).  • Pharmaceutical documentation (reporting and record-keeping and archiving).  • Document review (Reports, logbooks, protocols, SOP, batch production documents).  • Process review and Update of Quality Systems documentation.  • Investigation of deviations/Out of specifications, Change Control, Corrective and preventive action implementation (CAPA).  • Quality Inspection and Quality Auditing.  • Production in process/ inline control/testing/monitoring for critical quality attributes and specifications.  • Continuous quality improvement by Statistical data analysis and Statistical process control.  • Method Development, Method Validation, Cleaning Validation, and Process Validation.  • Equipment Qualification (VAT, SAT, IQ, OQ,PQ, CV) and Equipment Calibration.  • Pharmaceutical Microbiology and clean room management/control/monitoring.  • Raw material to finished product testing/re-testing and release protocol.  • Drug stability investigation and reporting.  • Raw material vendor appraisal, qualification and certification.  • HPLC and Empower-Waters software with knowledge of GC and MS  • Sample handling, Sample preparations, and Analysis as per the analytical method.  • Strong experience with the use of lab analytical equipment and troubleshooting (dissolution apparatus, disintegration apparatus, HPLC system, UV spectrophotometer, Hardness, and friability testers, weighing balances, Karl Fischer apparatus, etc.)  • Knowledge of IR and MS sample preparation and analysis  • Computer skills with various software (Trackwise, Microsoft Word, excel, power-point, Visio, Minitab, etc)