Job description
Sr Executive, QMS Posted by Leading Indian MNC in Pharma Ahmedabad Posted: imported by Jeevika JobsPopular categoriesIT jobsSales jobsMarketing jobsData Science jobsHR jobsEngineering jobsJobs in demandFresher jobsMNC jobsRemote jobsWork from home jobsWalk-in jobsPart-time jobsJobs by locationJobs in DelhiJobs in MumbaiJobs in BangaloreJobs in HyderabadJobs in ChennaiJobs in PuneCompaniesExplore categoriesUnicornMNCStartupProduct basedInternetExplore collectionsTop companiesIT companiesFintech companiesSponsored companiesFeatured companiesResearch companies by AmbitionboxInterview questionsCompany salariesCompany reviewsSalary CalculatorServicesAI career toolsNeo AI job agentResume score checkerAI resume makerInterview Q&AAI mock interviewLive AI interviewPremium servicesNaukri ProMost popularExpert resume writingExpert power profileAI BootcampsNewFree resourcesResume samplesJob letter samplesSearch jobs hereLoginRegisterFor employersBuy onlineNaukri Talent CloudEmployer LoginSr Executive, QMSAmneal Pharmaceuticals4.21.6K Reviews5 - 8 yearsNot DisclosedAhmedabadPosted: 1 week agoOpenings: 1Applicants: 100+Sr Executive, QMSAmneal Pharmaceuticals4.21.6K ReviewsJob description Description: Independently conduct and prepare investigation reports for Product Quality Complaints, Unplanned Deviations, OOS, OOT, and OOAL events, ensuring timely closure and regulatory compliance. Perform root cause analysis using appropriate tools (5-Why, Fishbone, Risk Assessment, etc.) and recommend effective corrective and preventive actions (CAPA). Initiate, review, track, and verify CAPA implementation and effectiveness within established timelines. Review and coordinate Change Controls related to processes, equipment, facilities, systems, materials, and documentation, including quality and regulatory impact assessments. Analyze and prepare annual trend reports for Unplanned Deviations, Complaints, CAPAs, OOS, OOT, and OOAL events to identify recurring issues and drive continuous improvement. Prepare Quality Metrics, Management Review reports, and periodic trend analyses for site leadership. Maintain QMS records in compliance with cGMP, Data Integrity (ALCOA+), and company procedures. Support internal audits, customer audits, and regulatory inspections. Assist in the development, review, and revision of SOPs and other quality system documents. Collaborate with Manufacturing, Quality Control, Engineering, Validation, and other cross-functional teams to resolve quality issues. Support inspection readiness initiatives and promote continuous improvement of Quality Management Systems. Ensure all activities are performed in compliance with applicable cGMP, FDA, ICH, company policies, and Health Safety requirements. Additional Skills Strong understanding of QMS principles and compliance. Knowledge of GMP, cGMP, GLP, GDP, and regulatory requirements from agencies such as the U.S. Food and Drug Administration, European Medicines Agency, and World Health Organization. Strong attention to detail to identify documentation errors and ensure data integrity. Strong written and verbal communication skills for preparing reports, leading discussions, and driving quality initiatives. Education: B. Pharm B. Pharm - Required M. Pharm M. Pharm - Preferred Experience: 5 years or more in 5 - 8 Years Specialized Knowledge: Licenses: Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.Role: QA / QC Executive,Industry Type: Biotechnology,Department: Quality Assurance,Employment Type: Full Time, PermanentRole Category: Production & ManufacturingEducationUG: B.Pharma in Pharmaceutical Analysis and Quality AssurancePG: Any PostgraduateKey Skillscaparisk assessmentquality controladministrationcgmpcustomer auditsregulatory complianceroot cause analysisquality managementproduct qualitycompliancemanufacturingauditscommunication skillsAbout companyAmneal Pharmaceuticals Private Limited is a global pharmaceutical company specializing in the development, manufacturing, and distribution of generic medicines, specialty pharmaceuticals, and biosimilars. The firm focuses on delivering affordable, high-quality healthcare solutions through advanced research, innovation, and large-scale production facilities. Career opportunities include roles in manufacturing, quality assurance, RD, regulatory affairs, and operations, reflecting its mission to improve patient access to essential medicines worldwide. Beware of imposters! Naukri.com does not promise a job or an interview in exchange of money. Fraudsters may ask you to pay in the pretext of registration fee, Refundable Fee…Read moreSimilar jobsExecutive - Quality Assurance (QMS)Bharat Serums and Vaccines3.9738 reviewsMumbai(Ambernath East)CapaQMSChange ControlAssuranceQualityChangeQuality assuranceControlPosted 25 Days AgoSr. Executive / Executive - Quality AssuranceIpca3.83877 reviewsTarapurGMP ComplianceQMSQuality assuranceQualityAssuranceGMPComplianceSRPosted 10 Days AgoQuality Assurance QMSPharmaceutical jobPosted by Krishna Placement ServicesAhmedabadQMSQuality AssuranceQuality Management SystemsQMS ImplementationManagementQualitySystemAssuranceManagement systemsPosted 9 Days AgoSr. Executive - QASymphony HrPosted by Symphoni HrMumbai (All Areas)(Tarapur)Quality AssuranceCAPAValidationUSFDAChange ControlAudit ManagementQMSGMPUSAssuranceControlData validationAuditingQualityPosted 10 Days AgoQuality Assurance InchargeFishfa Biogenics3.263 reviewsRajkotQa/QcActive Pharmaceutical IngredientCleaning ValidationProcess ValidationCapaChange ControlMarket ComplaintsOOSOOTSOPEquipment QualificationQMSInvestigationDeviationVendor QualificationProcessQualityComplaintsPosted 27 Days AgoRoles from top companiesQms ExecutiveLeading Indian MNC in Pharma2-7 Yrs4-9 Lacs P.A.AhmedabadHiring for one of these companies5d agoQuality Assurance ExecutiveLarge Pharma Company9-12 Yrs7-10 Lacs P.A.AhmedabadHiring for one of these companies1d agoRegister to unlockJobs you might be interested inVendor Qualification - CQAUnison Pharmaceuticals3.9287 reviewsAhmedabadPosted 20 Days AgoQuality Assurance QMSPharmaceutical jobPosted by Krishna Placement Service...AhmedabadPosted 9 Days AgoIPQA - Officer / Assistant ManagerZydus Lifesciences4.08250 reviewsAhmedabadPosted 13 Days AgoExecutive/Sr. Executive - Quality AssuranceIpca3.83877 reviewsDhar(Pithampur)Posted 10 Days AgoAssistant ManagerIntas4.15063 reviewsAhmedabadPosted 10 Days AgoReviewsView all1.6K employee reviews4.0rated by Quality Assurance Officer in AhmedabadLikesBest pharma company in AhmedabadDislikesNARead full reviewPowered bySalary insightsSenior Qms Executive in Amneal Pharmaceuticals typically earns between₹8.1 - ₹8.9 L/yrSee detailed salary breakupPowered byBenefits & PerksView all162 employees reported these benefitsTransport / Travel SupportHealth & Wellness SupportLearning & Development SupportFree MealPerformance BonusRelocation AssistancePowered by Recommended for youKnow moreAI-enhanced profileGet noticed by recruiters by increasing profile views upto 3 timesNaukri Pro builds an AI enhanced profile and keeps it active in searches. 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