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Regulatory Compliance Specialist for Pharmaceutical QC

1 month ago

Singapore NO DEVIATION PTE. LTD. Full time
Job Description:
No Deviation Pte. Ltd. is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who possess strong expertise in commissioning qualification validation (CQV) and quality compliance.
We uphold our core values of empathy, integrity, and transparency, striving to create a collaborative, innovative, and inclusive work environment that fosters personal growth and development.

Scope & Responsibilities:
​Provide guidance on commissioning/qualification activities
​Assist in change control assessments and reviews
​Conduct laboratory computer system data integrity assessments and reviews
​Lead the setup, configuration, and deployment of laboratory information management systems (LIMS) within the quality control (QC) department
​Work closely with QC and IT teams to ensure LIMS meets operational and regulatory requirements
​Customize LIMS workflows, forms, and reports to align with specific QC processes
​Develop and execute qualification and validation protocols for LIMS, ensuring compliance with relevant regulations (e.g., FDA 21 CFR Part 11)
​Perform system validation and testing to ensure LIMS functions as intended
​Document all qualification and validation activities in accordance with regulatory standards

Qualifications:
​Bachelor's degree in a relevant field (Chemistry, Biochemistry, Engineering, or similar)
​Minimum of 3-5 years of experience in QC within a regulated industry (e.g., pharmaceuticals, biotechnology)
​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
​Excellent project management and organizational skills

Estimated Salary:
$80,000 - $110,000 per annum