QC Manager

Quality Control Manager

Job Code: SBQC-001 Sudair Industrial City, Kingdom of Saudi Arabia Closing Date: May 31, 2023

  • 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.
  • 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)

    Do you have experience in Biologics?
    YesNo

    Do you have an EU-GMP experience?
    YesNo

    Do you have an experience in Establishing a Quality Control Lab?
    YesNo