Manager - MS&T

Novartis

  • Hyderabad, Telangana
  • Permanent
  • Full-time
  • 1 month ago
Job Description Summary The Global Change Control Manager oversees the entire process of managing GxP-impacting changes within the global manufacturing network. This role is responsible for the change control process from initiation, through impact assessment, planning, execution tracking, documentation, CAPA effectiveness, continuous improvement in change governance, and metrics reporting. The manager works closely with cross-functional teams such as Regulatory, Quality, Operations, to support timely implementation, risk management, and ongoing improvement in change governance. The role also contributes to audits, inspections as well.Job DescriptionKey Responsibilities:
  • Good Understanding of Global Change control process and able to advice on Global and Local Change request strategy.
  • Align between sites and Regulatory team regarding Change control plan, impact / implementation on sites.
  • Prepare the change request plans and present them for endorsement at the Change review board (CRB)
  • Open global change requests, assign impact assessment actions, and manage the lifecycle of Change Requests (CR).
  • Track and report the implementation status of change requests with cross-functional teams.
  • Manage and maintain change control documentation, including updates, version control, and compliance with cGMP and regulatory standards.
  • Facilitate change control review meetings, capturing key information and translating it into actionable and clear documentation.
  • Provide support during audits and inspections by ensuring accurate and readily available change control documentation.
  • Collaborate with cross-functional teams (Quality, Operations, Engineering) for accurate documentation.
  • Track and report metrics related to documentation timeliness, compliance, and quality.
  • Comply with internal processes like KPI reporting, ticket management, and functional requirements.
  • Contribute to process improvement initiatives by identifying and addressing gaps in change control documentation workflows.
  • Support and contribute to quality management system (QMS) actions such as Change Controls, CAPA, effectiveness checks (EC), risk assessments, and OOXs management. Participate in periodic QMS reviews to identify and contribute to areas of improvement where applicable.
  • Good Understanding of Process/Cleaning Validation and Technology transfer concepts and requirements including transfer protocols, validation protocols & reporting and comparability reports
  • Collaborate with site teams for Transport Validation / Shipping verification activities including validation risk assessment, testing protocols and reports.
  • Act as SPOC to drive key Global projects within the platform and collaborate with sites to ensure timely execution of tasks/ deliverables
Desirable Requirements:Bachelor's/Master degree in Pharmacy, Pharmaceutical Technology, Biotechnology, Chemistry, or equivalent science streams. Desirable MSc/MS. or equivalent experience.Good understanding of Radio Ligand Therapies (RLT) platformMinimum 10 years of experience in MS&T, Quality Assurance in Manufacturing of Biologics Drug substance and Drug Product.Hands on experience in 1-QEM tool.Strong understanding of Global change control processes, cGMP, and regulatory requirementsProven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions). PMP is added advantage.Expertise in document management system and writing technical reportsExperience in Health authority audits and Self inspections.Good communication, presentation and Interpersonal skills.Proficiency in English (oral and written) is mandatory.Essential Requirements:Quality / Accuracy / Right First TimeQuality System Management (Change Control, CAPA, Risk Assessment and EC) SupportAccuracy and compliance of change control documentationTimeliness of documentation updates and approvalsStakeholder satisfaction with documentation quality and usabilityAdherence to regulatory requirements during audits and inspectionsEffectiveness of standardized documentation processesSkills:Change Control ProcessEffective communicatorStrong cross functional collaborationBiologics Manufacturing ProcessProject ManagementGood Documentation PracticeEffective stakeholder engagementReport writingKnowledge Of GMP (Good Manufacturing Practices)Deviation managementCorrective and preventive action (CAPA)General HSE KnowledgeManufacturing (Production)Manufacturing Technologies.Process And Cleaning ValidationWhy Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-cultureYou’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewardsCommitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.Skills Desired Applied Statistics, Assembly Language, Change Control, Chemical Engineering, Continual Improvement Process, Cost Reduction, Data Analytics, Electronic Components, General Hse Knowledge , Including Gdp, Knowledge Of Capa, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Manufacturing Technologies, Process and Cleaning Validation, Process Control, Process Simulation, Risk Management, Root Cause Analysis (RCA), Scientific Method, Six Sigma, Statistical Analysis, Technology Transfer

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