Analyst (Wetlab Chemistry) is responsible for executing routine wet-chemistry analyses on raw materials, in-process, finished products and stability samples in strict adherence to approved test procedures, cGMP, GLP, 21 CFR Part 211, NABL ISO/IEC 17025 and ALCOA++ data-integrity principles. The role supports Sipra Labs' US FDA approval roadmap by ensuring accurate, timely and audit-defensible analytical results, with zero analyst-attributable invalid results.
SECTION 3: KEY RESPONSIBILITIES
• Receive samples from the sample custodian against ARN per SOP; verify identity, quantity and condition before commencing analysis.
• Execute wet-chemistry tests (titrimetry, gravimetry, pH, Karl Fischer, loss on drying, residue on ignition, viscosity, specific gravity, dissolution, UV-Vis) strictly per approved test procedures / pharmacopoeial methods (IP, BP, USP, EP).
• Enter raw data contemporaneously in approved logbooks, worksheets and SLIMS — adhering to Good Documentation Practice (GDP) and ALCOA++ principles.
• Return samples to custodian post analysis with proper documentation; maintain retention samples per SOP.
• Obtain review of all analytical work and results from designated reviewer / supervisor before report release.
• Report any Out-of-Specification (OOS), Out-of-Trend (OOT), incident, deviation or non-conforming event to the Section In-Charge / QA immediately per SOP.
• Enter and confirm test results in SLIMS accurately and within defined TAT; ensure traceability of analyst, reviewer and instrument records.
• Perform daily verification and scheduled calibration of assigned instruments (analytical balance, pH meter, KF titrator, UV-Vis); maintain instrument logbooks and PM compliance.
• Support method verification, method validation and method transfer activities under supervision.
• Maintain laboratory cleanliness, reagent and volumetric solution stocks (with valid expiry/standardization), and safe chemical-handling practices.
• Support internal audits, NABL surveillance, US FDA inspections, and client audits with complete and retrievable documentation.
• Adhere strictly to laboratory safety, PPE usage, chemical-handling SOPs and waste-disposal procedures.
SECTION 4: KEY PERFORMANCE INDICATORS (KPIs)
• Timely completion of allotted sample analyses: ≥ 95% within defined TAT.
• Zero analyst-attributable invalid results / repeat analyses.
• Zero critical Good Documentation Practice (GDP) / data-integrity observations in any internal or external audit.
• 100% adherence to instrument calibration schedule and logbook entry compliance.
• SOP training completion ≥ 95% within the 90-day induction window.
• Audit readiness – Nil repeat observations from NABL / US FDA / client audits.
SECTION 5: REQUIRED SKILLS / COMPETENCIES
• Strong fundamentals of analytical chemistry — volumetric, gravimetric, instrumental analysis.
• Working knowledge of cGMP, GLP, 21 CFR Part 11, 21 CFR Part 211 and ALCOA++ data-integrity principles.
• Good Documentation Practice (GDP) — legible, contemporaneous, attributable record keeping.
• Basic exposure / awareness of HPLC, GC, UV-Vis, IR, Karl Fischer titrators and dissolution apparatus.
• Software proficiency: MS Office; willingness to learn SLIMS and chromatographic software (Empower / OpenLAB / LabSolutions).
• Basic instrument troubleshooting and ability to follow escalation matrix.
• Effective written and verbal communication in English.
• Team orientation, discipline, integrity and a compliance-first mindset.
SECTION 6: TRAINING REQUIREMENTS
• Induction Training (Day 1–3) – Company orientation, HR policies, Sipra E-Book, safety awareness.
• cGMP / GDP / GLP training and assessment within 30 days of joining.
• Data Integrity & ALCOA++ training (21 CFR Part 11 principles) within 30 days.
• Instrument operation & calibration training – Analytical balance, pH meter, KF titrator, UV-Vis spectrophotometer, dissolution apparatus.
• Safety and chemical-handling training – PPE, MSDS, spill management, fire safety, waste disposal.
• SOP-wise role-specific training on applicable test methods, pharmacopoeial procedures and laboratory practices; minimum 95% completion before independent work allotment.