Team Member – Analytical QA

Job Summary
This role is for a Quality Assurance Specialist - Analytical Compliance, responsible for ensuring end-to-end adherence to regulatory standards and SOPs in Quality Control (QC) laboratory operations, with a focus on analytical data integrity, investigation management, and documentation oversight.

Roles & Responsibilities
. You will be responsible for participating in investigations of Quality Management System (QMS) documents such as OOS, OOT, and laboratory deviations, and ensuring timely closures as per SOP timelines.
. You will be responsible for preparing trending reports for OOS, OOT, and laboratory incidents, using analytical insights to support CAPA identification and process improvements.
. You will be responsible for evaluating Change Controls and CAPA action plans, verifying their effectiveness to ensure resolution of root causes and prevention of recurrence.
. You will be responsible for reviewing all analytical data generated in the Quality Control laboratory-including electronic and raw data-ensuring accuracy and compliance with relevant SOPs.
. You will be responsible for reviewing instrument and equipment calibration records and audit trails to confirm reliability, data integrity, and GMP adherence.
. You will be responsible for preparing and reviewing documentation related to stability samples and ensuring that reference standards, impurity standards, working standards, and related records are maintained per applicable procedures.
. You will be responsible for performing and verifying SAP transactions related to laboratory workflows and data entries as outlined in SOPs, ensuring traceability and accuracy.
. You will be responsible for reviewing and approving method validation and method transfer protocols and reports, as well as LIMS master data and control limit updates, ensuring analytical consistency across platforms.

Educational qualification: Graduation in Chemistry/Analytical Chemistry or Pharmacy is mandatory
Masters in Microbiology, Biochemistry, Biotechnology, Chemistry/Analytical Chemistry or Pharmacy is preferred
Additional Certifications like CQA, CPGP, CBSP, Six Sigma, ICH Q5/Q6, Advanced Biologics Manufacturing or RAC are preferred
Minimum work experience:
2+ years experience
Skills & attributes &Critical exposures
Functional Skills
. Regulatory Compliance
. Regulatory Filings
. Technical Documentation
. Change Control
. Laboratory Information
. Risk Management
. Chromatography
Resident Skills
. Product Quality (QA/QC)
. Current Good Manufacturing Practices (cGMPS)
. Good Laboratory Practice (GLP)
. Quality Management Systems (QMS)
Behavioural Skills
. Accuracy & Discipline - Upholds rigorous documentation and testing standards to ensure error-free, compliant results.
. Ownership - Proactively identifies risks, supports investigations, and maintains equipment readiness with accountability.
. Continuous Learning - Shares knowledge with new joiners, troubleshoots effectively, and contributes to laboratory excellence.
Critical exposures
. Experience in ensuring compliance with GMP, GLP, and global regulatory standards is desired.
. Exposure to executing analytical tests using techniques like HPLC, GC, FTIR, and UV-Vis, ensuring adherence to SOPs and regulatory requirements is preferred.
. Experience in maintaining accurate documentation and ensuring compliance with data integrity principles such as 21 CFR Part 11 and Annex 11, is desired.
. Experience in troubleshooting like Out-of-Specification (OOS) results and non-conformances, applying analytical methodologies to resolve deviations, is desired.
. For SME - Advanced Instrumentation: Experience in operating and maintaining advanced analytical instruments such as LC-MS, ICP-MS, and NMR, ensuring method development and validation, is desired.
. For SME - Statistical Analyst (Biologics): Experience in applying biostatistical methods for analyzing biologics data and process validation, using software like SAS or JMP, is desired.