Validation and Operational Quality Specialist

For Logistica A DP World Company

Job Purpose: Coordinate and oversee validation activities, including qualification and validation protocols, reports, risk assessments, and change controls, to ensure projects are executed efficiently and meet predefined quality, compliance, and business objectives.

Key Responsibilities :

• Quality strategy : Develop and implement a quality management strategy for validation and calibration processes.
• Standards systems : Develop and maintain systems to establish standards relating to activities and operational processes.
• GMP projects :
• Review and approve site validation plans for buildings, HVAC systems, services, and equipment.
• Ensure all validation activities and documentation comply with the recommendations of the Validation Master Plan.
• Follow up and participate in the change control system.
• Prepare the Calibration Master Plan and monitor its execution.
• Prepare and follow up on Validation Master Plans (VMP), Performance Qualification Protocols (PQP), and Validation Reports (VR) for activities such as:

1. Process validation

2.Validation review of all activities

3.Process equipment qualification

4.Facility qualification

5.CSV and software validation

• Printing process:

1.Review and approve overprinting batch records against customer requests.

2.Participate in investigations and resolve issues related to the overprinting process.

• Temperature monitoring:

1.Review weekly warehouse temperature records and communicate any issues to relevant customers.

2.Share temperature readings with customers upon request.

• Quality management system: Ensure the QMS is implemented and maintained.
• Customer complaints: Ensure complaints are handled effectively.
• Compliance: Ensure warehouse operations comply with GDP/GMP standards and instructions.
• OH&S: Comply with OH&S policy, standards, objectives, and training. Report any incidents (accidents or near misses) and participate in risk assessments.
• Environmental standards: Comply with environmental management standards, objectives, and training. Report environmental incidents immediately.

Qualifications & Skills:

• Bachelor’s degree in Science/Engineering or a related felid
• 1–3 years of experience in Quality Assurance, Validation, Qualification and Calibration.
• Good knowledge of Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Quality Management Systems (QMS).
• Proficiency in Microsoft Office applications
• Strong organizational skills with the ability to manage multiple tasks, priorities, and deadlines effectively.
• Excellent attention to detail and a high level of accuracy in document review and data management.
• Strong communication and interpersonal skills, with the ability to work effectively across different departments.