Specialized Material Sourcing: Develop sourcing strategies for APIs, excipients, solvents, chemicals, and other raw materials essential for drug formulation and production.
Work closely with R&D, quality assurance (QA), and regulatory teams to align sourcing strategies with product development timelines, compliance requirements, and market needs.
Engage in technical discussions with suppliers regarding the formulation, stability, and performance of pharmaceutical ingredients, ensuring they meet stringent specifications and quality standards....
Shall perform advanced analytical characterization of pharmaceutical drug substances, drug products, and excipients using pXRD, PSD, Microscopy, TGA, DSC, and DVS techniques.
Shall conduct solid-state characterization studies including polymorph identification, crystallinity assessment, phase transformation, and hygroscopicity evaluation.
Shall develop, optimize, qualify, and validate analytical methods for advanced characterization techniques as per project requirements....
Ensure compliance with regulatory requirements and quality standards in all production planning activities.
Hands-on SAP system on MM/PP Module for, Reservation, Process order.
To familiar with CGMP requirement along with change control, deviation and Investigation process related to production planning and supply chain management....
Material planning execution as per the Company’s material planning strategies to ensure timely availability of materials and components. Analyze forecast /demand reports received from demand planning team
Hands-on experience with SAP ERP & Proficiency in SAP Production Planning (PP) Module.
Develop and maintain material planning schedules based on production forecasts, sales demand, and manufacturing requirements....
Shall carry out stability testing & routine testing of drug product, comparative dissolution profiles ensuring delivery in accordance with project timelines.
Shall execute Assay & Dissolution methods development for drug substances.
Shall perform validation of analytical methods....
Bachelor’s Degree in Engineering, preferably Mechanical, Electrical, Chemical, or a related discipline.
Minimum 5 years of relevant experience in project engineering, CAPEX project management, or engineering projects, preferably within the pharmaceutical or regulated manufacturing industry.
Hands-on experience managing projects from feasibility, planning, and procurement through installation, commissioning, and handover....
Oversee literature survey, patent search, online documentation, design, development & execution of developmental batches of new products.
Supervise team members on preparation of Product Development Plans (PDP), Stability compilations, Product Development Reports in QBD approach, & various other technical documents for regulatory submission.
Review interpreted analytical results, & grounding decision-based activities for product development with minimum Supervision from upper management....