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. ## About the Role We are looking for an Officer QA to support Quality Assurance activities in our pharmaceutical analytical testing laboratory based in Navi Mumbai. This role focuses on Computer System Validation (CSV) execution and documentation, analytical data review, and review of instrument qualification and calibration records, ensuring compliance with GMP, GLP, data integrity, and laboratory quality requirements. ### What Youll Be Doing You will support and execute Computer System Validation activities for laboratory computerized systems, following approved validation procedures and regulatory expectations. This includes reviewing or executing documents like User Requirement Specifications, Functional/Design Specifications, Risk Assessments, Validation Plans, and Qualification documents (IQ/OQ/PQ), User Acceptance Testing, Traceability Matrices, and Validation Summary Reports. Youll also assess Gx. P applicability, data integrity, audit trails, electronic records, and electronic signatures. Youll coordinate validation test cases, document results and deviations, and support periodic review, change control, access management, and revalidation activities. Working with IT, lab teams, and vendors to resolve validation issues is key. You will also review qualification documentation for laboratory instruments and computerized analytical systems, including DQ/IQ/OQ/PQ and requalification records, verifying that protocols and reports meet predefined acceptance criteria. This involves reviewing calibration and qualification certificates, raw data, test results, and deviations. A significant part of the role involves performing independent review of analytical data from instruments such as HPLC, GC, LC - MS/MS, GC - MS, ICP - MS, IC, KF, UV, and other systems. Youll check raw data, chromatograms, spectra, calculations, worksheets, and system-generated reports for completeness, accuracy, and compliance with approved methods and SOPs. Youll verify calculations, integration parameters, system suitability results, sequence details, and sample preparation records. Youll also review electronic data for ALCOA+ principles and data integrity compliance, identifying atypical results, discrepancies, missing data, and audit trail concerns. Supporting QA disposition and release activities will be part of your responsibilities. You will help implement and maintain the laboratory QMS in line with GMP, GLP, ISO/IEC 17025, and data integrity expectations. This includes supporting internal audits, regulatory inspection readiness, reviewing SOPs and quality documents, monitoring compliance, and supporting training on data integrity and QA requirements. Staying up to date with regulatory expectations around data integrity, computerized systems, and electronic records is essential. Youll ensure all records are complete, attributable, legible, contemporaneous, original, accurate, and readily retrievable. Reviewing audit trails and identifying potential data integrity risks will be part of your daily work. ### What Were Looking For To succeed, youll need a Bachelors or Masters degree in Pharmacy, Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related discipline. You should have 25 years of relevant QA experience in a pharmaceutical, CRO, analytical testing, or contract laboratory environment. Hands-on experience in analytical data review is essential. Experience with Computer System Validation (CSV) execution and/or review is preferred, as is experience with instrument qualification and validation data review. Familiarity with HPLC/GC and other analytical lab systems is an advantage. Exposure to ALIMS/LIMS, CDS systems like Chromeleon or Open. Lab, and electronic document management systems is desirable. You should have a strong understanding of analytical lab operations, good knowledge of GMP/GLP and data integrity (ALCOA+), and an understanding of CSV lifecycle and risk-based validation. Youll need to be able to critically review qualification protocols, raw data, and reports, and be comfortable with electronic records, audit trails, and electronic signatures. Strong documentation and report-writing skills, along with proficiency in MS Office and electronic quality systems, are important. On a personal level, were looking for someone with strong attention to detail and analytical thinking, who can identify inconsistencies and compliance risks. You should have an independent and objective approach to data review, good communication and interpersonal skills, and the ability to work collaboratively with Analytical, IT, and external service providers. A strong commitment to data integrity, compliance, and quality is a must, along with the ability to manage multiple activities and meet timelines. ### Key .