Quality Assurance Specialist
2 months ago
No Deviation PTE. LTD. is a leading provider of patient-centric solutions for the pharmaceutical industry. Our company is committed to delivering high-quality services that meet the evolving needs of our clients.
Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team. The successful candidate will be responsible for providing guidance and direction on commissioning/qualification activities, assisting in change control assessments and reviews, and conducting laboratory computer system data integrity assessments and reviews.
Key Responsibilities- Commissioning and Qualification: Provide guidance and direction on commissioning/qualification activities to ensure compliance with regulatory requirements.
- Change Control: Assist in change control assessments and reviews to ensure that all changes are properly documented and approved.
- LIMS Implementation: Lead the setup, configuration, and deployment of the LIMS system within the QC department, ensuring that it meets all operational and regulatory requirements.
- System Validation: Develop and execute qualification and validation protocols for the LIMS, ensuring compliance with relevant regulations (e.g., FDA 21 CFR Part 11).
- Documentation: Document all qualification and validation activities in accordance with regulatory standards.
- Education: Bachelor's degree in a relevant field (Chemistry, Biochemistry, Engineering, or similar).
- Experience: Minimum of 3-5 years of experience in QC within a regulated industry (e.g., pharmaceuticals, biotechnology).
- Skills: Proven experience in LIMS implementation, configuration, and validation, strong understanding of qualification and validation processes in a GMP/GLP environment, proficiency in LIMS software (e.g., LabWare, STARLIMS, SampleManager) and laboratory automation.
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