全职 Validation Technician 工作, 薪水, STERIS Kedah 公司招聘中 - Ricebowl

Position Summary

Primary role is to cover all technical activities related to EO in the Site.

Duties

• Planning and execute of inspections incoming and outgoing, releasing, equipment calibration and products to ensure that all quality requirement are met.
• Report to the Validation Supervisor of any non-conformance in materials, equipment or products and to ensure that all non-conforming items are well labeled and segregated.
• Responsible for the launching, downloading, analysis, verification and calibration of data loggers. Coordinates the calibration and maintenance of process related equipment to ensure calibration is maintained within date and equipment operates as intended.
• Preparation of batch report, BI sterility test and certificate of sterilization.
• To ensure all records are prepared and maintained in according to STERIS procedure and made available for routine check at anytime.
• Preparation of validation protocols and report for processes.
• Liase with production for the validation mapping and head the mapping activity. Ensure mapping activity executed as per validation protocol.
• Verification of sterilization process and release of goods to customer.
• Works as directed by direct Supervisor to facilitate and support Customer EO qualifications within the EO Technical department.
• Carries out all aspects of their role and associated documentation in compliance with STERIS Quality Management System, ISO11135, ISO13485 and FDA regulatory requirements while adhering to GMP and GDP requirement.
• Complies with local and global procedures.

Duties - cont'd

12. Reviews qualification batch records for compliance to GDP and GMP, demonstrating a high level of attention to detail. Follows up with Operations to address and close out on any batch record queries within agreed timelines
13. Provides administration support to the EO Tech Team. Completes filing and archiving of qualification batch records and supporting EO qualification documentation.
14. Sets and agrees annual GPS performance objectives with direct Supervisor. Actively participates in performance management reviews in line with STERIS corporate requirements and timelines.
14. Actively participates in Team projects as agreed with direct Supervisor.
15. Performs according to the guidelines outlined in the STERIS Code of Business Conduct. Supports STERIS AST business imperatives of Safety, Quality, Customer Focus, Innovation, Sustainability and Lean.
16. Collaborates with all STERIS employees, Customers, auditors, and visitors to the site in a professional, constructive, and respectful manner. Encourages open communication providing timely and accurate responses.
17. Complies with Health and safety polices & procedures, reports any concerns, potential risks or hazards to the Health and Safety representative so appropriate action can be taken.

Education Degree

Required Experience