Pharmaceutical Technical Transfer Project Management
- Managing the technical aspects of your organisation projects which could be either cost saving, supply sustainability, technical transfer and regulator / technical driven initiatives
- Process include feasibility, planning and initiation of new projects, monitoring the progress, raising any associated risks, ensuring that time lines are defined and met therefore ensuring that product remains on the market with as little disruption of supply as possible
- Projects are measured on successfully completing critical milestones associated with project plans and meeting scheduled implementation dates
- Organize and host kick off meetings as required and defining the Project Scope, Objectives, Roles and Responsibilities with the project team
Implementation and Management of Quality Management System (QMS)
- ISO 9001 QMS Implementation and management
- Quality Auditing: API Manufacturers, Solid Manufacturing CMO’s, Distributors, Laboratories
- Concessions, Deviations and CAPA, Quality System Management Review
- Change Control Management
- Continuous Improvement Projects
- SOP Documents Review and implementation
- Writing and review of Technical Quality Agreements
- Annual Product Quality Reviews
- Management of Customer Complaints
GMP & GDP Quality Auditing
GMP and GDP Quality Auditing: API Manufacturers, Solid Manufacturing CMO’s, Distributors, Laboratories
- Plan, conduct and assess the cGMP compliance of Vendors through Audits
- Write and issue Audit reports timeously
- Review of Auditee CAPA reports to ensure the timely close of CAPA
- Preparations of Pre and Post Audits activities
- Periodic monitoring of vendor performance through risk management process
Regulatory Project Dossier Management
- Initiates the Regulatory Project Scope Assessment for various projects, where we assess the markets that are to be included in scope for submission, and their respective technical requirements as per the market guidelines
- Assist the Regulatory Compliance department with aligning the dossiers to market specific requirements for submission
- Manages Bioequivalence Studies through CMO for technical transfer projects, for the purpose of submissions in specific markets that require BE Studies
- Manages the acquisition of CPP with CMO for the purpose submission of dossier submission in MENA Regions
- Assist the in-Market Regulatory team to respond to deficiencies from Ministries of Health
- Compiles a Project Data pack from Manufacturing site for Compliance team to align it align to in-market CTD requirement, for submission to Ministry of Health
Site Registration Project Management
- Identify Markets that require site registration in a Site transfer Technical project
- Liaises with the various Regulatory Affairs affiliates in the market to register the specific product line manufactured by the specified site within their country’s Ministry
- Overseas all the Technical transfer Projects that require site registration, initiates and monitor progress through site registration dossier management tracker
- Arrange audits for contract manufactures when required by a specific health ministry for the purpose of Site registration
Training
- Operations Specific Procedures (initiation & maintenance of standard operating procedures – SOP)
- Good Manufacturing Practice (GMP)
- Quality Specific Training- Deviations, CAPAs, Change Controls
- Documentation Practices