Technocom Systems Sdn Bhd is looking for new potential candidates to fill in for QA ENGINEER (CSV) position. If you currently looking for new job opportunities and qualified with the job desc, feel free to apply this job.
- Lead validation projects and complete all associated project documentation in line with regulatory expectations;
- Participate in the qualification of third-party vendors pertains to production or quality related computerised system;
- Manage, coordinate and guide the execution of the site validation master plan;
- Provide the relevant support for regulatory audits, submissions and other auditor requests;
- Review validation protocols (this requires gaining an in-depth knowledge of the product to be able to determine what the necessary output is and if it is meeting predefined criteria);
- Ensure projects are managed in conjunction with all regulatory requirements such as health & safety, cGMP, environmental, etc;
- Provide guidance to validation team in developing and write commissioning, qualification and validation documents following established standards and templates;
- Ensure the validation status of equipment and systems are in compliance with cGMP at all times;
- Manage validation documentation, commissioning test scripts, qualification validation protocols, summary reports and risk assessments;
- Maintain validation documentation through the validation lifecycle;
- Provide evidence of both internal and external regulatory compliance;
- Ensure accurate records of all validation activities;
- Supervise a team of validation professionals;
- Participate in any special projects/programs as & when assigned by Company.
- Bachelor’s Degree in Computer Science/Information Technology/Manufacturing/Electrical/Electronics Engineering or Equivalent;
- Knowledge in Quality Management system, example ISO 9001, ISO 13485, FDA QSR is preferred;
- Knowledge in Process and System Validation is preferred;
- Knowledge in Electronics Record and Signature, example 21 CFR Part 11, is preferred;
- Knowledge in LEAN Six Sigma is preferred but optional;
- Proficiency in Microsoft Office, Computerized System and Security;
- At least 3-5 years’ experience in the Medical Device / FDA regulated industry and 3-5 years’ experience in either Quality Assurance, Quality Management, IT Compliance or equivalent, is an added advantage.
How To Apply
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