Department: Quality ControlEmployment Type: Full TimeLocation: SudairReporting To: Technical and Facility Operations Deputy DirectorDescription| Area of Responsibility || 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/procedures.| 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.| Skills, Knowledge and Expertise || Educational qualifications| Batchelor's Degree in Pharmacy, Chemistry, Biotechnology, Biochemistry or any other related field.| Master/PhD Degree in Pharmacy, Chemistry, Biotechnology, Biochemistry or any other related field.| Experience | >12 Year in Pharmaceutical/ Biotechnology Manufacturing Organization with EU-GMP environment.| >8 Years in multi-national Pharmaceutical/ Biotechnology Manufacturing Organization with EU-GMP environment.| Technologies/ Markets | Pharmaceutical/ Biotechnology Manufacturing Organization with EU-GMP environment.| Insulin Manufacturing