1 Global Pharma Iraq Job

Qualification/Functional knowledge

1Bachelors degree in Engineering in Instrumentation and control. Advanced degrees or specialized training are a plus.

2 Minimum of 5+ years of experience in calibration, instrumentation, or metrology in the pharmaceutical or biotechnology industry.

Hands-on experience with various types of calibration equipment and techniques.

3 Certifications (Preferred): Certification in Calibration (e.g., ASQ Certified Calibration Technician). Training in Good Manufacturing Practices (GMP) and regulatory compliance (e.g., FDA regulations).

4 Technical Proficiency: Strong knowledge of calibration principles, methodologies, and practices. Proficiency in the use of calibration tools and software (e.g., electronic test equipment, data loggers)

5 Analytical Skills: Ability to analyze data, interpret results, and make informed decisions based on findings. Strong problem-solving skills to identify issues and implement effective solutions. 6 Communication Skills: Excellent verbal and written communication skills for effective collaboration with cross-functional teams. Ability to prepare detailed technical reports and presentations.

7 Familiarity with regulatory requirements in the pharmaceutical industry (e.g.; SCADA, Ample logic, SAP, EQMS, CSV etc.) 8

Knowledge of safety standards and regulations in construction.

9 Ability to work collaboratively in a team-oriented environment.

CALIBRATION MANAGEMENT

Development of Procedures:

• Develop the standard operating procedures (SOPs) for calibration processes of all pharmaceutical instrumentation in QC, R&D pilot and all manufacturing facilities.
• Ensure calibration procedures meet regulatory requirements (e.g., FDA, ISO 17025) and industry best practices.

Execution of Calibration:

• Perform routine calibrations according to established schedules, ensuring minimal disruption to manufacturing and laboratory operations.
• Utilize calibrated reference standards and specialized calibration equipment to perform accurate measurements.
• Calibration Software:
• • Use and manage calibration management software for scheduling, tracking, and documenting calibration activities and results.
• • Generate calibration certificates and reports that document compliance with procedures and standards.

• EQUIPMENT MAINTENANCE
• Troubleshooting:
• • Identify and troubleshoot issues related to instrumentation and control systems, implementing corrective actions as necessary.
• • Coordinate with engineering and maintenance teams to address non-conformance issues and ensure timely resolution.
• Vendor Coordination:
• • Liaise with external vendors for the calibration and maintenance of specialized equipment, ensuring compliance with company standards.
• • Manage contracts and service agreements related to calibration services.
• DOCUMENTATION AND COMPLIANCE
• Record Keeping:
• • Maintain detailed records of calibration activities, ensuring documentation is complete, accurate, and up-to-date.
• • Ensure all calibration records are archived in accordance with company policies and regulatory requirements.
• Audit Preparation:
• • Prepare for internal and external audits by ensuring all calibration documentation is readily accessible and compliant.
• • Assist in audit responses and corrective action plans related to calibration findings.
• COLLABORATION AND SUPPORT
• Cross-Functional Teamwork:
• • Work closely with Quality Assurance (QA) and Quality Control (QC) teams to support validation activities for new equipment and processes.
• • Collaborate with R&D teams during the development and qualification of new instruments.
• Training and Mentorship:
• • Provide training to laboratory and production personnel on calibration techniques, equipment usage, and SOPs.
• • Mentor junior calibration engineers and technicians in best practices and regulatory compliance.

• CONTINUOUS IMPROVEMENT
• Process Optimization:
• • Identify areas for improvement in calibration processes and implement strategies to enhance efficiency and effectiveness.
• • Conduct root cause analysis for calibration failures and develop preventive measures to avoid recurrence.
• Stay Updated:
• • Keep abreast of industry trends, new calibration technologies, and changes in regulatory requirements through ongoing education and professional development.