Job Description
- Perform equipment verification and calibration according to established protocols.
- Document all test results in compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
- Ensure quality records are completed, attached, and/or filed as required.
- Review completed test records, approve QC samples/lot dispositions in the Laboratory Information Management System (LIMS), and manage the release of raw materials, solvents, packaging materials, and intermediates.
- Perform maintenance, troubleshooting, and qualification of laboratory equipment as necessary.
- Conduct equipment qualification and analytical method validation as needed.
- Maintain compliance with documentation and quality standards in accordance with GMP and GLP policies.
- Train colleagues on equipment operation, analytical and microbiological testing methods, and general laboratory procedures.
- Review and approve test results in the Laboratory Information Management System (LIMS).
- Analyze test results, advise on their significance, and recommend appropriate actions.
- Investigate and resolve laboratory issues such as out-of-specification results or equipment malfunctions, identifying root causes and implementing corrective and preventive actions.
- Develop and validate analytical test methods as required.
- Manage laboratory equipment validation projects with minimal supervision.
- Review test reports and ensure all laboratory documentation complies with regulatory requirements and remains inspection-ready.
- Write and update Quality Procedures and develop Standard Operating Procedures (SOPs) for laboratory instruments and processes.
- Plan and deliver technical training to colleagues, developing training materials as needed, such as basic lab techniques.
- Collaborate closely with cross-functional teams and external vendors to ensure objectives are met, including equipment installation, validation, service contracts, and external testing requirements.
Requirements
- Min Bachelor's Degree in science
- Demonstrated technical skills in method validation and testing
- Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures, and governmental regulations
- Knowledge of Good Manufacturing Practices and its application standards, processes and policies
Interested candidates are invited to email your resume to:
Jenalyn Ooi Huai Sian (R1765551)
Recruit Express Pte Ltd | Company Reg. No. 199601303W | EA License Number: 99C4599
We regret only suitable candidates will be shortlisted for an interview.
