Summary The purpose of the Specialist role is to work collaboratively with Site MS T team and multifunctional technical operations teams in Large molecules platform The individual plays a key role in facilitating effective communication between teams and supporting problem-solving activities Maintain the oversight on Process and Validation activities executes preparation and updating of Risk assessments and documentation for Validation activities About the Role Major accountabilities Chemical Biochemical and or Biotechnological Expertise Valuable understanding of physico chemical properties of chemicals and buffers e g buffer capacity stability including basic analytical methods e g pH conductivity density Good understanding of biotechnological processes e g fermentation cell cultivation techniques purification techniques e g filtration chromatography Basic understanding of biochemical processes Experiences in preparation of Nitrosamine Raw material risk assessments and declarations for residual solvents and Elemental Impurities Validation Expertise Create validation documentation including process validation protocol reports risk assessment ongoing process verification OPV plans reports cleaning validation protocol reports based on alignment with Site Validation Lead Preparation of Transport Validation Verification Protocols and conduct the necessary studies in coordination with cross functional teams Collect the results and create the reports Ensure all collected data is accurate and comprehensive and that protocols comply with regulatory requirements and organizational standards Support in prepration and updation of Hazard Analysis Critical Control Point HACCP Control strategies and FMEA risk assessments Ensure the timely availability of technical documentation as per Novartis guidelines Perform OPV CPV evaluations assess process performance and provide insight recommendation and conclusion to the site MS T team Create and update process excursion signals PES Review key documents and coordinate input for relevant registration documents to ensure accuracy and completeness Ensure all site validation activities comply with Novartis requirements and GMP managing any deviations related to these activities including oversight of pre validation and validation resulting from technical changes Possess a fundamental understanding of pharmaceutical analytical testing Ensure project tracking documentation tools are updated according to plan Collaborate closely with the development organization or sending site for technical transfers and new product launches to ensure knowledge transfer appropriate control strategies risk analysis and control and readiness for commercial process validation Coordinates prerequisites for PPQ batches Qualification status Status of the analytical methods raw materials consumables updates Risk Assessments for Microbial buffer hold validation and generates deviation lists for PPQ batches Preparation approval and life cycle management of Gxp documents Ensure that data integrity checks are conducted to verify that all the data is complete consistent and free from errors before proceeding with any further analysis or reporting Coordinates documentation review with the site MS T QA and QC also Reg CMC where applicable Manufacturing Excellence Desired to be familiar with Manufacturing Process Transfer Contribute to process improvement and optimization for product transfers Training Own the Training Curriculum for Own Job Profile Ideal Background Requirements for the role Bachelor s degree in pharmacy Pharmaceutical Technology Chemical Engineering Biotechnology Chemistry or equivalent science streams Desirable MSc MS or equivalent experience Min 5 years of experience in MS T or in the manufacturing of pharmaceutical Drug substance in Large Molecules platform facility Should be familiar with regulatory guidance on validation product filing and post approval changes Proven project management experience in a cross-functional environment e g multi-site technical development other functions Expertise in reviewing and writing technical reports Good communication Presentation and Interpersonal skills Key Performance indicators Quality Accuracy Right First Time Timeliness Deviations Escalations Skills Effective communicator Conflict management Change Control Continual Improvement Process Efficiency Employment Discrimination Flexibility General HSE Knowledge Good Documentation Practice Knowledge Of CAPA Knowledge Of GMP Good Manufacturing Practices Lean Manufacturing Manufacturing Production Manufacturing Process Process Control Production Line Productivity Risk Management Root Cause Analysis RCA Well-Being Languages English Why Novartis Helping people with disease and their families takes more than innovative science It takes a community of smart passionate people like you Collaborating supporting and inspiring each other Combining to achieve breakthroughs that change patients lives Ready to create a brighter future together https www novartis com about strategy people-and-culture Join our Novartis Network Not the right Novartis role for you Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up https talentnetwork novartis com network Benefits and Rewards Read our handbook to learn about all the ways we ll help you thrive personally and professionally https www novartis com careers benefits-rewards Division Operations Business Unit Universal Hierarchy Node Location India Site Hyderabad Office Company Legal Entity IN10 FCRS IN010 Novartis Healthcare Private Limited Functional Area Technical Operations Job Type Full time Employment Type Regular Shift Work No Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities If because of a medical condition or disability you need a reasonable accommodation for any part of the recruitment process or in order to perform the essential functions of a position please send an e-mail to email protected and let us know the nature of your request and your contact information Please include the job requisition number in your message Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve