Quality Assurance Specialist III

Quality Assurance Specialist III Bangalore, Karnataka, IndiaThe QA Specialist provides independent Quality support for GLP and GCLP studies by performing document review, protocol and experiment record review, data review, and quality event oversight activities. The role focuses on ensuring data integrity, traceability, and compliance with internal SOPs and applicable regulatory expectations, while maintaining strict independence from study execution.This position includes high-value QA activities that can be performed remotely, with controlled system access and clear separation from operational responsibilities.Essential duties include but are not limited to:Study-Audit SupportSupport execution of internal audits by:Create study-specific audit schedule prior to First patient-in (FIP) for study-specific auditCreate audit plan, execute, and draft the report for each scheduled audit (interim or associated with the final report) using objective, evidence-based language under QA lead oversightExecute the audit through the review of controlled document, including:SOP alignmentVersion verificationStudy governing documents (Lab manual, Project Specification Document, Data Transfer Agreement, clinical protocol)Conduct QA review of clinical protocols, sample analysis protocols (SAP/SAR) and amendments, ensuring:Version verificationInternal consistencyAlignment with study objectives and SOPsAssure closure of quality events pertaining to study at the time of data reportingPerform QA review (sampling) of experiment records / batch records, including:Need access to LIMS/BSI and other systems hosting data sourceEnsure alignment between protocol-defined activities and recorded executionTraining status of staffQualification status of equipment and reagentsConduct QA review (sampling) against DTA of data tables, listings, and summaries, including:Table-to-source traceability (raw data → output)Internal consistency checksSample ID reconciliation and data alignment (BSI)Apply data integrity (ALCOA+) principles during review of electronic data systemsComputerized Systems Audit SupportSupport execution of internal audits by:Preparing audit checklistsCompiling pre-audit document packagesAssisting with document-based audit reviewsProvide audit preparation support, including:Evidence list preparationPre-audit document collectionDraft audit reports and summaries using objective, evidence-based language under QA lead oversightData Integrity AssessmentConduct data integrity audits of paper and electronic recordsEvaluate:Audit trails and metadataSystem controls (e.g., access, security, validation)Data lifecycle controls (collection, processing, reporting)Assess compliance with:ALCOA+ principles21 CFR Part 11 / Annex 11 for electronic systemsIdentify:Data discrepancies, manipulation risks, or gapsSystem vulnerabilities affecting data reliabilityMiscellaneous:Assist in training new and existing personnel, as neededParticipate in regulatory, notified body, and customer audits as neededProvide back-up coverage for other Quality SpecialistsCarry out other duties/projects as assignedQualifications:Minimum Required:Bachelor's Degree or Master Degree in Life Sciences, Pharmacy, Biology, Chemistry4 years of related experience in a life science GxP environment with CRO experience preferredHands-on experience with:ICH-GCP (E6 R2/R3)FDA regulations (e.g., 21 CFR Part 11)EMA / EU CTR / Annex 11GxP frameworks (GCP, GMP, GLP, GCLP)Preferred certification:ASQ Certified Quality Auditor (CQA)ISO 9001 / ISO 13485 Lead AuditorGxP Lead Auditor certifications (e.g., CQI/IRCA)Clinical QA certifications (e.g., CCQAP)Other Required:High attention to detailStrong written and verbal communicationAbility to meet deadlines and perform administrative functionsData review expertise across computerized systems including LIMSUnderstanding of Audit trails, metadata, and system validationKnowledge of Computer System Validation (CSV) and Computer System Assurance (CSA)Data governance frameworksMust be able to interpret raw data vs reported data discrepanciesMicrosoft Office suite proficiency including Office Word, Excel, PowerPointAbility to organize tasks, work independently and adapt to changing prioritiesAbility to function independently within a minimally supervised environment with exceptional attention to detail requiredDemonstrated highly developed communication skills including well-developed writing skills and verbal and interpersonal skillsMust be able to read, write, speak, fluently and comprehend the English language