The role will work closely with R&D, QC, QA, Production, Regulatory Affairs, Engineering and other cross-functional teams to support analytical method lifecycle management and ensure inspection readiness.
Key Roles & Responsibilities
Analytical Method Validation (AMV)
- Plan, coordinate, execute, and document analytical method validation activities.
- Prepare, review, and execute Analytical Method Validation Protocols and Reports.
- Perform analytical method validation in accordance with current applicable guidelines, including ICH Q2(R2) and relevant regulatory requirements.
- Evaluate method suitability based on the intended purpose and analytical procedure.
- Perform validation studies for:
- Assay
- Related substances / impurities
- Dissolution
- Content uniformity
- Identification
- Preservative content
- Residual solvents
- Water content
- Elemental impurities, where applicable
- Other physicochemical and chemical analytical methods
- Evaluate validation parameters such as:
- Specificity
- Accuracy
- Precision
- Repeatability
- Intermediate precision
- Linearity
- Range
- LOD
- LOQ
- Robustness
- Solution stability
- Filter compatibility, where applicable
- Establish scientifically justified acceptance criteria.
- Review and interpret validation results against predefined acceptance criteria.
- Identify atypical trends or failures during validation and initiate appropriate investigations.
- Ensure validation activities are completed within approved timelines.
Analytical Method Development Support
- Support development and optimization of analytical methods in collaboration with R&D / Analytical Development.
- Evaluate analytical procedures for specificity, sensitivity, precision, accuracy and robustness.
- Support optimization of HPLC/UPLC/GC chromatographic conditions.
- Evaluate column selection, mobile phase, flow rate, wavelength, temperature and other chromatographic parameters.
- Support forced degradation studies and assessment of degradation products, where applicable.
- Evaluate analytical method suitability for stability studies and routine QC testing.
- Provide technical support for troubleshooting analytical methods.
- Analytical Method Verification
- Perform verification of compendial/pharmacopoeial analytical methods before routine implementation.
- Ensure verified methods are appropriately implemented in the QC laboratory
- Analytical Method Transfer (AMT)
- Coordinate analytical method transfer activities between:
- R&D and QC
- Sending laboratory and receiving laboratory
- Different manufacturing sites
- Contract laboratories, where applicable
- Prepare/review Analytical Method Transfer Protocols and Reports.
- Coordinate transfer testing and ensure availability of required standards, samples, reagents, columns and equipment.
- Evaluate transfer results against predefined acceptance criteria.
- Identify and investigate transfer discrepancies.
- Support resolution of analytical method transfer issues.
- Ensure successful completion and documented closure of method transfer activities.
Analytical Testing & Instrumentation
Perform or supervise analytical testing using applicable laboratory instruments, including:
- HPLC
- UPLC
- GC
- UV-Visible Spectrophotometer
- FTIR
- Dissolution Apparatus
- Karl Fischer Titrator
- pH Meter
- Conductivity Meter
- TOC Analyzer
- Analytical Balance
- Other laboratory analytical instruments as applicable
Responsibilities include:
- Execute testing according to approved specifications, analytical methods, SOPs and STPs.
- Ensure proper instrument operation and system suitability.
- Review chromatographic data and analytical calculations.
- Ensure appropriate handling and storage of samples, standards, reagents and solutions.
- Support troubleshooting of analytical instruments and methods.
- Ensure instrument usage and laboratory activities are appropriately documented.
Validation Documentation & Good Documentation Practices
- Prepare, review, and maintain:
- Validation Protocols
- Validation Reports
- Method Transfer Protocols
- Method Transfer Reports
- Method Verification Protocols/Reports
- Standard Test Procedures (STPs)
- SOPs
- Specifications
- Analytical worksheets
- Validation raw data
- Calculation sheets
- Instrument records
- Laboratory logbooks
- Ensure documentation complies with Good Documentation Practices (GDP).
- Ensure all analytical data are complete, accurate, traceable and attributable.
- Maintain appropriate laboratory records and validation-related documentation.
Ensure timely review, approval and archival of validation documents
Data Integrity
- Ensure compliance with ALCOA+ principles for laboratory and validation data.
- Ensure analytical data are:
- Attributable
- Legible
- Contemporaneous
- Original
- Accurate
- Complete
- Consistent
- Enduring
- Available
- Review electronic analytical data and audit trails where applicable.
- Ensure appropriate control of electronic records and computerized laboratory systems.
- Identify and report potential data integrity concerns.
- Support data integrity assessments and remediation activities.
OOS / OOT / Deviation Investigation
- Participate in investigation of:
- Out-of-Specification (OOS) results
- Out-of-Trend (OOT) results
- Atypical results
- Laboratory errors
- Analytical failures
- Method-related deviations
- Perform technical assessment of analytical data.
- Support laboratory Phase-I and Phase-II investigations, as applicable.
- Perform root cause analysis using appropriate investigation tools.
- Recommend scientifically justified corrective and preventive actions.
- Ensure investigation records are complete and compliant with applicable procedures.
CAPA, Change Control & Risk Assessment
- Initiate and/or support CAPA related to analytical methods and laboratory investigations.
- Participate in analytical change control activities.
- Assess impact of changes to:
- Analytical methods
- Instruments
- Columns
- Reagents
- Reference standards
- Specifications
- Testing procedures
- Software/computerized systems
- Conduct or support risk assessments for analytical processes.
- Evaluate the need for partial or complete method revalidation following changes.
- Monitor CAPA effectiveness and ensure timely closure.
Stability Study Support
- Support analytical testing associated with stability studies.
- Ensure approved and validated/verified analytical methods are used for stability testing.
- Review stability analytical data for trends and atypical results.
- Support investigation of OOS/OOT results observed during stability studies.
- Ensure stability samples, standards and analytical records are properly controlled and documented.
Regulatory & Pharmacopoeial Compliance
Ensure analytical activities comply with applicable requirements, including:
- ICH Q2(R2) – Validation of Analytical Procedures
- ICH Q14 – Analytical Procedure Development, where applicable
- WHO-GMP
- US FDA requirements
- EU-GMP requirements
- Applicable regulatory requirements
- Indian Pharmacopoeia (IP)
- United States Pharmacopeia (USP)
- British Pharmacopoeia (BP)
- Other applicable pharmacopoeial requirements
- Monitor relevant changes in analytical and regulatory requirements.
- Assess the impact of pharmacopoeial revisions on existing analytical methods.
- Support implementation of revised pharmacopoeial methods and requirements.
Audit & Regulatory Inspection Support
- Support internal audits, customer audits and regulatory inspections.
- Ensure validation and analytical documentation is readily available and inspection-ready.
- Provide technical responses to auditor/inspector questions related to analytical validation.
- Support preparation of responses to audit observations.
- Implement and monitor actions arising from audits and inspections.
Ensure analytical laboratory practices remain compliant with regulatory expectations.
Training & Team Development
- Provide training to QC personnel on:
- Analytical methods
- Method validation
- Method transfer
- Method verification
- Data integrity
- GDP
- Analytical instrument operation
- Relevant SOPs
- Ensure personnel are trained and qualified before performing assigned activities.
- Maintain training records.
Mentor junior QC analysts and provide technical guidance
Cross-Functional Coordination
Work effectively with:
- Quality Assurance
- Quality Control
- R&D / Analytical Development
- Production
- Regulatory Affairs
- Engineering
- Warehouse
- Microbiology
- Contract Testing Laboratories
Coordinate technical activities and provide analytical support for product development, technology transfer, validation, investigations and regulatory requirements.
Pay: From ₹1.00 per month
Benefits:
- Commuter assistance
- Paid sick time
- Paid time off
- Provident Fund
Work Location: In person
