Technical Expert MS&T
Novartis
- Hyderabad, Telangana
- Permanent
- Full-time
Provide all vital information to generate the validation documentation.Support Validation Lead and Experts to assess need and plan validations, assess revalidation need.4. Launch & Transfer Support - for product(s) /Sites assigned:Participate in external supplier / product evaluation and selection process. Responsible for gathering technical information on manufacturing process capability at the site/external supplier.Provide the necessary data for the technical activities involved in Tech Transfer of a product through the appropriate documentation, focusing on existing knowledge. Support technical activities at the giving / receiving site as needed.Define product acceptance criteria for the transfer, agree on acceptable performance with receiving organization and supervise routine manufacturing performance following transferEnsure successful and well-documented transfers and launches of products with external manufacturing involvement.Active support for Product Launch and Transfer governance processes5. Interface to Development for the product(s) /Sites assigned:Ensure that new products and processes are well developed for the commercial scale and the entire product lifecycle at the commercialization siteProvide guidance to formal stage gates during development and up to first OPV/APR/PQR as part of the development process to ensure early integration and to ultimately meet manufacturing requirementsSupport development of comprehensive control strategy early on in the development to ensure that validation requirements meet regulatory requirements and other critical metrics (e.g., quality, safety, environmental, cycle times, etc.).6. Manufacturing & Operational Excellence - for defined product(s) /Sites assigned:Define and implement design and control optimization projects where needed.Provide SME expertise to perform process characterization of pharmaceutical processes to increase adaptability and sustainability.7. Training:Lead the Training Curriculum for its Job Description and direct reports.Role RequirementsWhat you'll bring to the role:Essential Req·1. Education (minimum/desirable):Bachelors/Masters. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree.
Desirable MSc. or PhD.2. Languages:Fluent in English & Local Language of the respective Country.3. Relevant Experiences:Proven experience of 8+ years in pharmaceutical (chemical) manufacturing.Experience in a global/matrix environment in the pharmaceutical industryComprehensive know how in pharmaceutical (chemical) technologyProject Management experienceDrug Development experienceSound experience of data handling and applied statisticsYou'll receive:
Breakdown of benefits received in this role. Include flexible working, learning and development opportunities as well.Why Sandoz?Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!The future is ours to shape!Functional AreaTechnical OperationsDivisionSANDOZBusiness UnitNON-NVS TSA GLOBAL FUNCTIONS STOEmployment TypeRegularCommitment to Diversity & Inclusion:We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Shift WorkNoEarly TalentNo