Assistant Lab Executive

Job Description :

The PIC for Production Record Documentation, Lab Equipment Calibration, and ISO Documentation is responsible for maintaining accurate and up-to-date production records, ensuring laboratory equipment is calibrated regularly, and managing ISO-related documentation to meet compliance and regulatory standards. This role is crucial for maintaining product quality, supporting audits, and ensuring that all production and lab processes comply with established standards.

Key Responsibilities :

1. Production Record Documentation
   • Prepare, update and maintain accurate production records, including batch manufacturing records, material usage logs, and production reports.
   • Ensure that all production documentation is complete, signed, and follows company protocols and regulatory standards.
   • Collaborate with production teams to identify and resolve any inconsistencies or issues in documentation.
2. Lab Equipment Calibration
   • Develop and implement a schedule for the calibration of all laboratory equipment according to standard operating procedures (SOP).
   • Conduct routine checks and calibration activities to ensure lab equipment is functioning correctly and accurately.
   • Maintain calibration certificates and logs, and ensure records are readily available for audits and inspections.
   • Coordinate with third-party vendors for specialized calibration needs and maintain records of external calibration.
3. ISO Documentation Management
   • Manage ISO documentation processes, including document control, SOP updates, and compliance tracking.
   • Prepare and maintain required ISO documents and records for audits and regulatory inspections.
   • Collaborate with quality assurance (QA) and regulatory compliance teams to ensure ISO Standards are met consistently.
   • Conduct periodic reviews of ISO documentation and recommend updates to align with current best practices.
4. Audit Preparation and Compliance
   • Support internal and external audits by providing accurate and up-to-date documentation.
   • Implement corrective actions and continuous improvements identified during audits to improve compliance and quality.
   • Conduct regular training sessions on documentation standards and calibration processes for production and lab teams.
5. Data Analysis and Reporting
   • Collect and analyze data from production records and calibration logs to identify trends, areas for improvement, and potential quality risks.
   • Prepare and present monthly reports on documentation status, calibration outcomes, and ISO compliance to management.

Qualifications:

• Diploma or Bachelor’s degree in Science, Engineering, Quality Management, or related field.
• Experience in production record documentation, laboratory calibration, or quality documentation, preferably in a manufacturing or laboratory environment.
• Strong knowledge of ISO standards (ISO 9001) and regulatory requirements.
• Proficiency in using documentation management software and calibration tools.
• Excellent organizational, communication, and analytical skills.