Job Description

28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently. Your key responsibilities: Your responsibilities include, but not limited to: . The Technical specialist supports MS&T team on sites by collecting data, reviewing or writing technical documents related to validation (e.g. process validation, ongoing process verification, cleaning validation, packaging), APR PQR, technical files, product risk assessment procedures and maintaining a product oversight throughout the lifecycle. The scope includes all drug products bulk (DP), finished products (FP) and all chemical intermediates/APIs under Novartis responsibility. For that purpose, technical specialist collects data from the Novartis Business Units, act in accordance with legislation, internal rules, good practices and business objectives. . Support Validation program including process validation, ongoing process verification (OPV), risk assessment, cleaning validation, ongoing cleaning verification for Novartis drug product and drug substance manufacturing sites. 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. . Using monitoring tool such as OPV Monitor or Discoverant perform, OPV evaluations, assess process performance and provide insight, recommendation, and conclusion to the site MS&T Lead/Product Steward. Create and review GxP documents including SOPs, working procedures, trend reports, and technical investigations, as and when needed . Support tasks related to technical changes, incident investigations for the product and process. Provide active support during internal and external audits by collecting and presenting the requested process/ data and reports. Coordinate & manage project for a smooth knowledge transfer activity from site/ function to Operations Center. Act as single point of contact for the services delivered to sites/ functions by the respective team, including the review of feedback and timely completion of identified actions. . Coordinates with Global MS&T team, IT team for the ongoing data management, evaluation and reporting in the OPV Monitor OR Discoverant tool. Coordination of documents preparation in the right formats (eg. Novstyle for Subway, ESOPS etc) and ensure timely review and approval of the documents. Ensure services are delivered on time and in line with partner and Novartis MS&T requirements . Coordinates documentation review with the site MS&T, QA, and QC, also Reg CMC where applicable. Obtains deviation reports from relevant systems in support to validation to enable conclusions. Coordinates and owns DI check with Data integrity manager where applicable. Coordinates inputs from respective functions (QA, QC, MS&T), to create the validation documents and decide on the study strategy. Coordinates the execution of the study with respective functions. Collects results and creates reports. Diversity & Inclusion / EEO Minimum Requirements What you\'ll bring to the role: . Min 3 years of experience in MS&T, Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substance or drug products. Hands on experience in ongoing process validation or continued process verification. . Minimum of 3 years of pharmaceutical process validation and cleaning validation. Should have the experience in pharmaceutical process validation protocol/report writing, cleaning validation protocol and report writing, in sterile manufacturing setups, biologics. . Should be familiar and able to perform basic statistical evaluations using Minitab or other statistical analysis tools. Basic knowledge on deviation handling, incident investigations, root cause analysis, and CAPA management . Knowledge of risk assessment and risk management programs. Should be familiar with regulatory guidance on validation, product filing and post approval changes. Basic knowledge of statistical analysis, results interpretation, and usage of statistical tools (Example: Minitab, Statistics etc.) . Good communication, presentation and interpersonal skills. Fluent in English (oral and written). Bachelor\'s degree in Pharmacy, Pharmaceutical Technology, Chemical Engineering, Chemistry or equivalent science streams. Desirable M.Sc./MS. or equivalent experience. Why Novartis 766 million lives were touched by Novartis medicines in 2021, and while we\'re proud of this, we know there is so much more we could do to help improve and extend people\'s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what\'s possible, when we collaborate with courage to aggressively and ambitiously tackle the world\'s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! 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 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. 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:

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