Senior QC Analyst

1 week ago

Bhavnagar, India Adrta Technologies Private Limited Full time

The Senior QC Analyst ensures that LIMS and laboratory-related software modules are designed, validated, and tested according to pharma QC and laboratory standards. They serve as Subject Matter Experts (SMEs) for QC workflows, guiding product and development teams to build lab-compliant, user-friendly, and audit-ready features. Key Responsibilities - Review, validate, and optimize QC laboratory workflows inside the software (sample management, COA generation, stability studies, instrument management, batch analysis). - Perform detailed functional testing of LIMS, ELN, and QC modules, ensuring accuracy and compliance. - Work with pharma QC teams to gather user requirements and convert them into system workflows. - Ensure compliance with ALCOA+, Data Integrity, GxP, audit trails, and laboratory regulatory expectations. - Prepare test scripts, validation documents (IQ/OQ/PQ), COA templates, and QC process documentation. - Support client onboarding, LIMS configuration, and implementation. - Provide SME insights on: - Chromatography Data workflows (CDS) - Instrument integration - Method development and validation - Chemical/standard/solution management - Column management and usage logs - Stability study management - Recommend product enhancements based on QC pain points, regulatory gaps, and market requirements. - Review batch-related documents such as BMR (Batch Manufacturing Record), BPR (Batch Packaging Record) and support APQR (Annual Product Quality Review) workflow design in the system. Skills Required - Strong understanding of pharma QC processes: - Sample management, Chemicals & reagents, Standards & solutions preparation, Column management, COA generation, Analytical testing, Batch analysis, Stability testing. - Knowledge and practical understanding of: - Method development & validation, APQR, BMR, BPR workflows. - Experience with LIMS, ELN, CDS, or other lab digital systems. - Understanding of regulatory expectations: GxP, ALCOA+, Data Integrity, Audit Trails. - Good communication and documentation skills to work effectively with clients and internal teams. Experience Required - Minimum 5 years of experience in Pharma QC, Analytical Lab, LIMS, ELN, or laboratory workflow systems. Salary Range - ₹10,00,000 to ₹16,00,000 per annum (10–16 LPA) - (Based on experience & interview performance)

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