Quality Assurance Coordinator

Exeltis Pharmaceuticals

Minimum Requirements:

• University or Master's degree (Chemist, Chemical Engineering, Pharmacy, Biology)
• Min. 5 years’ experience in Quality Assurance
• Advanced English verbal and written communication skills
• High attention to detail
• Proficient in Microsoft Office
• Proficient in Microsoft Outlook
• Knowledge of good documentation practices is preferred
• Good knowledge of SAP, Trackwise, LIMS and Office Programs is preferred
• Good at preparing risk assessment and Time Management.
• Having a good level of Quality Mindset.
  

Principal Duties and Responsibilities:

• We are looking for an experienced quality assurance coordinator to oversee all aspects of quality management. The quality assurance coordinator's responsibilities include inspecting processes, and products, ensuring compliance with new and existing quality standards and regulations, implementing quality management actions, and contributing to the development of company policies and procedures. The quality coordinator provides quality support to projects from the planning phase to project completion.
• Ensuring compliance with current regulations.
• Monitoring and reporting on all activities, processes, and procedures.
• Developing internal auditing tools and conducting internal audits and reports.
• Determining data-driven solutions and implementing quality improvement plans.
• Performing regular inspections and reviews to ensure employees adhere to quality and safety policies.
• Assisting with the development of company policies, processes, and procedures.
• Providing departments with quality planning and support.
• Conducting or assisting with regulatory and quality training sessions.
• Preparing and maintaining quality management documentation.
• Monitoring and reporting on all activities of supplier and to execute the supplier qualification
• Provide expertise in validation ensuring compliance with current industry regulations, guidelines and trends.
• Reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria. Including but not limited to:
  

o   Qualification of premises, equipment and utilities.

o   Computer system qualification.

o   Computer system change control management.

o   SAP Master data management.

o   Laboratory equipment validation.

o   Process validation.

o   Cleaning validation.

o   Prepare and maintain policies and SOPs associated with validation.

o   Ensure that all change controls are assessed for impact on validation.

o   Review and Approval of validation master plans.

o   Review of deviations and non-conformances associated with validation activities.

o   Review and provide input into the periodic review and revalidation programme.

o   Participate in cross-functional project teams as the quality assurance validation representative.

• Participate in Continuous Improvement programs.
• Participate in other projects as directed by the Quality Assurance Manager.
• Flexibility is important and responsibilities may change or other duties may arise for this position.
• Proactively work to ensure schedules are maintained.
• Build quality into all aspect of the operations by maintaining compliance to all quality requirements
• Report to Quality Manager & QP of the site