Specialist MS&T

As a Specialist in the Site MS&T team within the Large Molecules Platform at Novartis Healthcare Private Limited in Hyderabad, India, you will work closely with multifunctional technical operations teams. Your role involves executing and supporting Technical Transfers and Life Cycle Management activities, with a strong emphasis on preparing and updating Risk assessments and Validation related documentation. Key Responsibilities: - Utilize Validation and Life Cycle Management Expertise to prepare process and cleaning validation documentation, conduct change evaluations, and ensure compliance with cGMP requirements - Support process validation lifecycle activities and participate in pre-validation activities and risk assessments - Provide technical expertise for quality risk assessments, including physico-chemical buffer stability risk assessments and evaluation of corrosive agents - Prepare Nitrosamine, raw material risk assessments, and declarations for residual solvents and elemental impurities - Assist in Extractable and Leachable (E&L) risk assessments, coordinate E&L studies, and maintain accountability for the site during audits - Support Hazard Analysis Critical Control Point (HACCP) and Control strategies - Contribute to OPV/CPV preparation and assessment of process performance - Update process excursion signals (PES) in the monitoring system and ensure project tracking documentation/tools are up to date - Collaborate with the development organization for technical transfers and new product launches - Coordinate prerequisites for PPQ batches and update Risk Assessments for Microbio buffer hold validation - Manage Gxp documents" life cycle and ensure data integrity checks are conducted - Coordinate documentation review with various departments Training: - Develop and own the Training Curriculum for your Job Profile Qualifications Required: - Bachelor's degree in pharmacy, Pharmaceutical Technology, Chemical Engineering, Biotechnology, Chemistry, or equivalent science streams; MSc/MS or equivalent experience preferred - Minimum 5 years of experience in MS&T or pharmaceutical manufacturing in Sterile/Large Molecules platform/facility - Familiarity with regulatory guidance on validation, product filing, and post-approval changes - Proven project management experience in a cross-functional environment - Expertise in reviewing and writing technical reports - Excellent communication, presentation, and interpersonal skills - Proficiency in English required; Knowledge of German is an advantage If you are passionate about making a difference in patients" lives through innovative science, collaborating with a community of smart and dedicated individuals, and creating breakthroughs, consider joining Novartis.,