Technical Director
The Stability Laboratory
مجموع سنوات الخبرة :28 years, 8 أشهر
responsible for the development, implementation, and maintenance of all technical aspects of a production. This individual will lead a team of technicians to ensure successful execution of the production.
Duties and Responsibilities
• Oversee the technical design and delivery of the production
• Develop and maintain technical standards for the production
• Monitor equipment and systems to ensure they are in peak working condition
• Troubleshoot and resolve technical issues in a timely manner
• Work with other departments to ensure technical requirements are met
• Manage the budget and resources allocated to the production
• Provide training and guidance to the technical team
• Maintain a safe and secure working environment
High capability in managing and operating most advanced laboratory
Equipments (i.e. TOC-Total organic carbon, Atomic Absorption,
Fluorometer, …etc).
_ Supervises the examination of Raw Materials through performing highly Technical Laboratory methods by Using i.e. TLC, GC, HPLC, and UPLC, to ensure it's suitability for the process of Manufacturing high Quality of finished products.
_ Supervises the testing of finished products (medical and pharmaceutical
Products i.e. Solids, Semisolids, solution, .etc), to make sure that it's
specifications are up to the USP, PB, and EP, before it's release to the market.
_ Supervises the stability studies (i.e.: Accelerating, long term, and on going) for
different Products to qualify for Registration at different markets .
_ Capability of establishing Quality Control Systems for Medical,
Pharmaceutical and Chemical laboratories .
_ Skilled Manager with ability to train, supervise and motivate staff to achieve
a relaxing working environment plus communication skills that makes Quality
Control Department an effective support to the factory.
- Ability to manage outsourcing of raw materials either for R&D development or for commercial products .
- Providing all regulatory documentation needed by regulatory affairs department through communication with raw material manufacturers .
Establishing the Quality Department for Chemical & Microbiology Lab system & furniture .
-Establishing the documentation system for Quality Control (Specification, Methods, Forms, Labels, Procedures…..etc)
- Reviewing and approving all Standards of Operating Procedures (SOP's).
- Organizing system of Sampling, Testing, & Released for all the Materials receipt in warehouse (Raw material, Packaging Material) & Rejected System for material not complied with specifications .
-Performed OOS System (Out of Specification) for all materials or products
doesn’t Complies with specification.
-Check all Activates in Quality Control & all reports.
-Communicates successfully with all Departments of the factory to achieve
solutions for arising problem.
_ Place purchase orders for Lab Materials and new lab Equipments and
Devices after thorough studies of quotations.
- Follow up of all registration demands concerning raw materials and packaging materials from regulatory affairs for the registration and
re-registration of finished products ( DMF, CEP, ……..)
• Skilled Purchasing and Logistics Manager with ability to train, supervise and motivate to achieve a relaxing working environment plus communication skills that makes Purchasing and Logistics Department an effective support to the factory.
• Supervising the implementation of the logistics and purchasing function plans, as well as ensuring their compliance with PR’s rules and policies.
• Conducting analysis on transportation routes and made recommendations for cost savings.
• Developing and implementing logistics plans to support company operations.
• Monitoring inventory levels and coordinated with suppliers to ensure the timely delivery of materials.
• Collaborating with cross-functional teams to ensure seamless operations across departments.
• Coordinating transportation and logistics activities, including shipment scheduling and tracking.
• Managing inventory levels and ensured timely delivery of materials.
• Conducting analysis of transportation costs and made recommendations for cost savings.
• Experience in requirements of ISO 17025 for contract labs and ISO 9001 for quality management.
• Managing the receipt and consolidation of supply, equipment and services requests that are acquired through shorter term transactional agreements such as the standard Purchase Order with the Agency; oversees the processing of Invitation to Tenders, Requests for Proposals and Requests for Quotes; evaluates tender submissions and awards contracts in accordance with the prevailing delegated authority.
• Liaising with Agency's suppliers in respect to relevant logistical and administrative aspects of their orders and delivery schedules; manages the vendor list associated with the short-term ordering process.
• Checking suppliers' claims and invoices before they are submitted for payment and liaises with Finance Staff as necessary and maintains accurate and up-to-date records including bids and offers received from suppliers.
Skilled Manager with ability to train, supervise and motivate staff to achieve a relaxing working environment plus communication skills that makes Quality Control Department an effective support to the factory.
− Capability of establishing Quality Control Systems for Medical, Pharmaceutical and Chemical laboratories.
− Ability to manage outsourcing of raw materials either for R&D development or for commercial products.
− Coordinate requests for projects with analytical staff and work with them to ensure the project requirements (pertaining to analyses) are clearly defined and communicated.
− Participates in manufacturer’s evaluation, through analysis of samples of starting materials supplied and reviewing records supplied by the manufacturer.
− Supervises sampling, testing and release of all incoming, starting packaging and other materials.
− Participates in updating the department SOP's, specifications and methods of analysis documents.
− Contributes in the monitoring of compliance with GMP and Good Quality Control Laboratory Practice within the department and organization.
− Reviews certificates of analysis and analyst (s) daily reports for starting / packaging materials and finished product.
− Ensures proper handling of primary reference standards and supervises the preparation of working standards and its periodic reanalysis as proper.
− High capability in managing and operating most advanced laboratory Equipment’s (i.e. HPLC, LCMS, GCMS, ICP, GC…. etc.).
− Supervises the testing of finished products (medical and pharmaceutical Products i.e. Solids, Semisolids, solution, .etc), to make sure that it's specifications are up to the USP, PB, and EP, before it's release to the market.
− Supervises the stability studies (i.e.: Accelerating, long term, and ongoing) for different Products to qualify for Registration at different markets.
− Allocates work assignments, coaches, monitors, and evaluates staff; establishes work plans and set priorities; participates in recruitment and selection of new staff and provides advice and guidance on professional development, communicates strategic issues, and builds cohesion, commitment, and confidence.
− Performed OOS System (Out of Specification) for all materials or products doesn’t Complies with specification.
− Follow up of all registration demands concerning raw materials and packaging materials from regulatory affairs for the registration and re-registration of finished products (DMF, CEP…).
− Skilled Manager with ability to train, supervise and motivate staff to achieve a relaxing working environment plus communication skills that makes Quality Control Department an effective support to the factory.
− Capability of establishing Quality Control Systems for Medical, Pharmaceutical and Chemical laboratories.
− Ability to manage outsourcing of raw materials either for R&D development or for commercial products.
− Coordinate requests for projects with analytical staff and work with them to ensure the project requirements (pertaining to analyses) are clearly defined and communicated.
− Participates in manufacturer’s evaluation, through analysis of samples of starting materials supplied and reviewing records supplied by the manufacturer.
− Supervises sampling, testing and release of all incoming, starting packaging and other materials.
− Participates in updating the department SOP's, specifications and methods of analysis documents.
− Contributes in the monitoring of compliance with GMP and Good Quality Control Laboratory Practice within the department and organization.
− Reviews certificates of analysis and analyst (s) daily reports for starting / packaging materials and finished product.
− Ensures proper handling of primary reference standards and supervises the preparation of working standards and its periodic reanalysis as proper.
− High capability in managing and operating most advanced laboratory Equipment’s (i.e. HPLC, LCMS, GCMS, ICP, GC…. etc.).
− Supervises the testing of finished products (medical and pharmaceutical Products i.e. Solids, Semisolids, solution, .etc), to make sure that it's specifications are up to the USP, PB, and EP, before it's release to the market.
− Supervises the stability studies (i.e.: Accelerating, long term, and ongoing) for different Products to qualify for Registration at different markets.
− Allocates work assignments, coaches, monitors, and evaluates staff; establishes work plans and set priorities; participates in recruitment and selection of new staff and provides advice and guidance on professional development, communicates strategic issues, and builds cohesion, commitment, and confidence.
− Performed OOS System (Out of Specification) for all materials or products doesn’t Complies with specification.
− Follow up of all registration demands concerning raw materials and packaging materials from regulatory affairs for the registration and re-registration of finished products (DMF, CEP…).