QA System Validation Supervisor

17 hours ago

Chennai, Tamil Nadu, India UPS Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Avant de postuler à un emploi, sélectionnez votre langue de préférence parmi les options disponibles en haut à droite de cette page.

Découvrez votre prochaine opportunité au sein d'une organisation qui compte parmi les 500 plus importantes entreprises mondiales. Envisagez des opportunités innovantes, découvrez notre culture enrichissante et travaillez avec des équipes talentueuses qui vous poussent à vous développer chaque jour. Nous savons ce qu'il faut faire pour diriger UPS vers l'avenir : des personnes passionnées dotées d'une combinaison unique de compétences. Si vous avez les qualités, de la motivation, de l'autonomie ou le leadership pour diriger des équipes, il existe des postes adaptés à vos aspirations et à vos compétences d'aujourd'hui et de demain.

Fiche de poste :

Job Summary
The Healthcare Quality Assurance (QA) System Validation Supervisor provides guidance to UPS Supply Chain Solutions (SCS) Information Technology (IT) department to maintain validation of warehouse and/or support systems utilized for healthcare applications. This position assesses systems being evaluated for use in healthcare applications and provides training and subject matter expertise to achieve and maintain validated status. He/She identifies systems requiring validation, elevates validation issues appropriately, and provides validation expertise. This position manages validation documents, determines applicable regulations, and reviews and approves testing of changes to validated systems.
Job Description
  • Knowledgeable in 21 CFR Part 11, Annex 11, and GAMP 5
  • Updates validation procedures, including change control, training, and audits, to ensure the maintenance of system validation.
  • Writes and reviews technical validation documents (e.g., validation plan, URS, FRS, Risk Assessment, Traceability Matrix, IQ/OQ/PQ/OPQ protocol, report, etc.)
  • Assists in system validation project activities (e.g., writing protocols, reviewing/approving test scripts, drafting validation reports, etc.)
  • Review and approve Change Control requests and assesses the impact on system validation status.
  • Review and approve procedures, forms, and manuals.
  • Perform audit trail reviews and document results.
  • Perform system validation status evaluations and complete reports.
  • Assist with supplier qualification assessment data gathering.
  • Investigate, review, approve, and perform corrective actions for deviations (i.e., nonconformances and CAPAs) and audit findings.
  • Maintains the document management system for healthcare facilities and distribution centers to ensure required documents and data are available for regulatory agency audits and inspections
  • Supports internal and external audits
  • Supports validation project status reports to communicate project goals, contingency plans, and issue resolutions to project teams and clients
  • Supervise direct reports, as appropriate
  • Lead cross functional groups
  • Flexible to work in different time zones
Mandatory Skills: Proficient with Microsoft Office applications (Word, Excel, and PowerPoint)
Qualifications:
  • Bachelor's degree in a relevant field (e.g., Information Technology, Computer Science, Data Science, or related discipline).
  • Overall, 7 years of experience with 2+ years of experience in quality assurance, manufacturing, or compliance within a GMP-regulated industry.
  • Knowledgeable in 21 CFR Part 11, Annex 11, and GAMP 5
  • Must be an effective collaborator and communicator
  • Must be well organized
  • Must have proficiency with Microsoft Excel, word and PowerPoint.
  • Knowledge of Process Analysis/Continuous Improvement are required
Tasks identified:
  • Provides guidance to UPS Supply Chain Solutions (SCS) Information Technology (IT) and Engineering departments to maintain validation of warehouse and/or support systems utilized for healthcare applications.
  • Identify systems used in healthcare that require validation and assess and evaluate the applications for system validation requirements.
  • Consults with internal groups (e.g., Operations, Business Development, IT, etc.) and investigates and resolves healthcare issues to ensure compliance with rules and regulations.

Type de contrat:

en CDI

Chez UPS, égalité des chances, traitement équitable et environnement de travail inclusif sont des valeurs clefs auxquelles nous sommes attachés.

  • Senior Validation Engineer – Male and Female

    2 weeks ago

    Chennai, Tamil Nadu, India Tek Support Full time

    Job Title: Senior Validation Engineer Trainer – CSV, CQV & CleaningLocation: RemotePosition Type: Part-timeJob Summary:We are seeking an experienced Senior Validation Engineer Trainer with a decade of proven expertise in Cleaning Validation, Computer System Validation (CSV), and CQV (Commissioning, Qualification, and Validation) within the pharmaceutical...

  • Cognos with QA

    2 weeks ago

    Chennai, Tamil Nadu, India Virtusa Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    We are seeking a detail-oriented QA Analyst to join our Cognos reporting team. The ideal candidate will be responsible for validating data accuracy, ensuring report functionality, and supporting the quality assurance process for both existing and newly developed Cognos reports and dashboards.Key Responsibilities:Review and validate Cognos reports and...

  • Senior Validation Engineer – Male and Female

    2 weeks ago

    Chennai, Tamil Nadu, India Tek Support Full time

    Job Title: Senior Validation Engineer Trainer – CSV, CQV & CleaningLocation: RemotePosition Type: Part-timeJob Summary:We are seeking an experienced Senior Validation Engineer Trainer with a decade of proven expertise in Cleaning Validation, Computer System Validation (CSV), and CQV (Commissioning, Qualification, and Validation) within the pharmaceutical...

  • Senior AI Model Validation Specialist

    1 week ago

    Chennai, Tamil Nadu, India beBeeDataCentric Full time ₹ 4,00,000 - ₹ 8,00,000

    Job DescriptionWe are seeking a skilled AI Model Tester to join our team. As an AI Model Tester, you will be responsible for developing and executing test plans and cases for AI/ML models and agent-based systems.Key Responsibilities:Develop and execute test plans and cases for AI/ML models and agent-based systemsConduct bias testing, data drift analysis, and...

  • QA Test Engineer

    15 hours ago

    Chennai, Tamil Nadu, India Capgemini Engineering Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job DescriptionQA / Test Engineer – Digital Twin of ShipsLocation: Chennai, IndiaWork Mode: Hybrid (3 days/week from office)Experience Required: 9–12 yearsQualifications: Bachelor's or master's degree in engineeringAbout the RoleWe are looking for a detail-oriented and technically skilled QA / Test Engineer to join our Digital Twin of Ships team. This...

  • QA Professional

    1 week ago

    Chennai, Tamil Nadu, India beBeeQuality Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    Delivering Quality ExcellenceWe are seeking a meticulous and skilled QA Analyst to join our team in upholding the highest standards of quality and reliability in our flagship mobile franchise.This is a remote position with night shifts from 2:30 AM to 11:30 AM IST. The ideal candidate will be responsible for developing and executing tests on new features,...

  • Supervisor of Production Leadership

    2 weeks ago

    Chennai, Tamil Nadu, India beBeeProduction Full time ₹ 15,00,000 - ₹ 25,00,000

    **Job Title:** Supervisor of ProductionWe are seeking an experienced and skilled Supervisor of Production to join our team. The successful candidate will be responsible for leading a team of technicians and production operators, ensuring a collaborative and highly motivated work environment.Key Responsibilities:Manage production schedules to boost...

  • Process Validation

    16 hours ago

    Chennai, Tamil Nadu, India HCLTech Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Role & responsibilitiesJob Title Manufacturing Engineer/Process Validation EngineerLocation – ChennaiDelivery looking immediate joiner onlyConduct detailed gap assessments of current manufacturing practices against applicable medical regulatory standards (e.g., FDA, ISO 13485, EU MDR, GMP).Review process controls, equipment validation, and quality systems...

  • Qa Engineer

    19 hours ago

    Chennai, Tamil Nadu, India Innova Solutions Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Job DescriptionMust-Have:Selenium ,API, Cucumber & Performance Testing (Jmeter-Pref)Key Responsibilities:Drive QA activities and ensure smooth day-to-day testing operationsDefine and deliver comprehensive test strategies and planning deliverablesAssist with test environment setup and readiness verificationDevelop and execute test cases/scriptsConduct root...

  • QA Engineers

    1 week ago

    Chennai, Tamil Nadu, India Photon Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    About The Role   QA Skills:- Functional and system testingAnomaly reportingSoftware analysisBlack box and white box testingData validation functional and system service testingTest suites, test cases and scriptsAgile/Scrum experience desiredTechnical Skills:- Experience working with defect management, test management and collaboration toolsJIRA,...