Officer - QA

At ALS, we encourage you to dream big. When you join us, youll be part of a global team harnessing the power of scientific testing and data-driven insights to build a healthier future. Job Description Officer QA Department: Quality Assurance Designation: Officer QA Reporting To: Assistant Manager / Manager QA Location: Navi Mumbai 1. Job Purpose To support Quality Assurance activities in a pharmaceutical analytical testing laboratory, with specific responsibility for Computer System Validation (CSV) execution and documentation, analytical data review, review of instrument qualification/calibration records and ensuring compliance with applicable GMP, GLP, data integrity and laboratory quality requirements. 2. Key Responsibilities A. Computer System Validation (CSV) Support and execute Computer System Validation activities for laboratory computerized systems in accordance with approved validation procedures and applicable regulatory expectations. Review and/or execute validation documents including: User Requirement Specifications (URS) Functional/Design Specifications Risk Assessments Validation Plans Configuration/Installation/Operational Qualification documents User Acceptance Testing (UAT) Traceability Matrix Validation Summary Reports Participate in assessment of GxP applicability, data integrity, audit trails, electronic records and electronic signatures. Execute or coordinate validation test cases and document test results, deviations and evidence. Review validation documentation and ensure that requirements are adequately tested and traceable. Support periodic review, change control, access management and revalidation activities for computerized systems. Work with IT, laboratory and system vendors to resolve validation-related issues. B. Instrument Qualification Data Review Review qualification documentation for laboratory instruments and computerized analytical systems. Review DQ/IQ/OQ/PQ and requalification records, as applicable. Verify that qualification protocols and reports adequately address predefined acceptance criteria. Review calibration and qualification certificates, raw data, test results and associated deviations. C. Analytical Data Review Perform independent review of analytical data generated from laboratory instruments such as HPLC, GC, LC-MS/MS, GC-MS, ICP-MS, IC, KF, UV and other analytical systems. Review raw data, chromatograms, spectra, calculations, worksheets, system-generated reports and analytical results for completeness, accuracy and compliance with approved methods and SOPs. Verify calculations, integration parameters, system suitability results, sequence details, sample preparation records and acceptance criteria. Review electronic data for ALCOA+ principles and data integrity compliance. Identify atypical results, discrepancies, missing data, audit trail concerns and potential data integrity issues and escalate them appropriately. Review analytical data packages and support QA disposition/release activities where applicable. D. Quality Management System Support implementation and maintenance of the laboratory QMS in accordance with applicable requirements such as GMP, GLP, ISO/IEC 17025 and data integrity expectations, as applicable. Support internal audits and regulatory inspection readiness activities. Review SOPs, forms, protocols and quality documents related to laboratory operations. Monitor compliance with approved SOPs and identify opportunities for continual improvement. Support training and awareness initiatives related to data integrity and QA requirements. E. Regulatory Compliance & Data Integrity Maintain awareness of current regulatory expectations relating to data integrity, computerized systems, electronic records and analytical laboratory controls. Ensure that electronic and paper records are complete, attributable, legible, contemporaneous, original/true copy, accurate and readily retrievable. Review audit trails and other electronic records as defined by procedures and risk assessment. Identify and escalate potential data integrity risks or compliance gaps. 3. Qualification & Experience Education: Bachelor's or Master's degree in Pharmacy, Chemistry, Analytical Chemistry, Pharmaceutical Sciences or a related discipline. Experience: 25 years of relevant experience in Quality Assurance within a pharmaceutical, CRO, analytical testing or contract laboratory environment. Hands-on experience in analytical data review is essential. Experience in Computer System Validation (CSV) execution and/or review is preferred. Experience in instrument qualification/validation data review is preferred. Experience with HPLC/GC and other analytical laboratory systems will be an advantage. Exposure to ALIMS/LIMS, CDS systems such as Chromeleon/OpenLab and electronic document management systems is desirable. 4. Technical Competencies Strong understanding of analytical laboratory operations and analytical data. Good knowledge of GMP/GLP and data integrity principles .