- Apply scientific knowledge to develop, qualify, optimize, and validate applicable assays for testing raw materials (incl. packaging and single use material), IPC, bulk/ API, and final product as well as for environmental monitoring and stability testing.
- Responsible for coordination and execution of all validation- and qualification activities for laboratory equipment.
- Establishment and responsibility for environmental monitoring of the GMP facility.
- Creating and updating qualification project plans and timelines for laboratory equipment.
- Perform assessments and review of change controls.
- Manage coordination of samples at external testing laboratories for testing, including sample and shipping information, as necessary.
- Develop and modify Quality control SOPs/ Policies.
- Develop, implement, and review SOPs for analytical methods and instruments within the department.
- Implement and review stability studies, validation documentation, change controls and investigations to maintain compliance with internal needs and regulations and regulatory requirements.
- Provide leadership, coaching support, and direction to the Quality Control team.
- Monitor contract laboratory activities to ensure compliance and timeliness of certificates of analysis and reports and review QC data and participate in batch release.
- Hiring, developing, training, and evaluating QC personnel.
- Assist the team leader of Validation in drafting and revising master validation/qualification documents as needed for the validation/qualification of analytical test procedures or equipment. In addition, manage contractors engaged in drafting validation protocols, execution of validation studies and completing of validation reports.
- Manage and provide oversight of the internal and external quality control laboratories for in process controls, raw materials testing, stability testing, release testing, (Microbiology, Chemical & Physical Test), and testing of packaging components.
- Review of specifications for Packaging Materials, Raw materials, Bulk and Finished product.
- Review and approve testing results according to defined specifications and managing the releases to meet operations demands.
- Maintain laboratories and ensuring adequate supply of equipment/reagents/etc. for daily operations.
- Provide knowledge and information to investigate deviations. Manage the timelines for investigations, CAPA review, and approval within the department.
- Ensure compliance with regulatory requirements according to sFDA and EU guidelines.
- Create a safe working environment, enforce, and monitor all safety practices/procedure.
- Review of data of stability studies, trend analysis of monitoring results, Packaging material, bulk, IPC samples and final product test results and statistical assessment.
- Perform routine quality reporting on OOS, Changes, stability studies and trend analysis.
- Prepare and organize training SOPs within the department and verify that training has been satisfactory prior to executing tasks within the lab and provide ongoing technical training.
- Within area of responsibility, understand and comply with all safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state, and local regulations.
- Proactively identify ways to improve systems, workflow and overall efficiency in the lab and take the appropriate action to implement change.
- Ensures training is up to date within the department and to develop teams and individuals to increase professional and personal competence.
Qualifications & experiences
- Batchelor’s Degree in Pharmacy, Chemistry, Biotechnology, Biochemistry
- 12 Years in Pharmaceutical/ Biotechnology Manufacturing Organization with EU-GMP environment and significant part of experience obtained in international pharma/biotech manufacturing organizations.
- Having a MS or PHD Degree and or Insulin experience is a nice to have.
- Business Results Oriented
- Excellent Leadership and Management
- Excellent Team Development
- Expert Intercultural Sensitivity
- Highly Proactive and Expert in Acting with Urgency
- Excellent collaboration and Influencing
- Fluent in Arabic and English (Verbal and Written)