Executive, Indore
Executive, Indore
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Indore, India
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Posted: less than a week ago
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Description
Purpose To support and execute technology transfer activities for pharmaceutical formulations from R&D to manufacturing sites or between two manufacturing sites, ensuring robust, compliant, and reproducible commercial production. Position / Job Title Executive Technology transfer Department Technology Transfer Reporting To Asst. General Manager/General Manager Location IndoreYears Of Experience Minimum of 3-5 years of experience in Technology Transfer, Formulation Development, or Manufacturing Operations in a pharmaceutical formulation company. Dosage Form Solid&Semi solid Job Responsibilities / Deliverables Technology Transfer Activities Execute technology transfer of oral solid or semi-solid formulations from R&D / pilot scale /commercial scale at one manufacturing unit to another commercial manufacturing unit Prepare, review, and execute Technology Transfer Protocols (TTP) and Technology Transfer Reports (TTR). Coordinate with R&D, Production, QA, QC, Regulatory Affairs, and Engineering during transfer activities. Support scale-up and scale-down studies and process optimization. Manufacturing&Process Support Assist in process validation, including PPQ batches and commercial batch execution. Troubleshoot manufacturing issues during trial, exhibit, and validation batches. Ensure correct transfer of critical process parameters (CPPs) and critical quality attributes (CQAs). Support equipment qualification and process capability studies.Documentation&Compliance Prepare and review manufacturing instructions, BMR/BPR, SOPs, and process flow diagrams. Ensure compliance with cGMP, ICH, USFDA, EMA, WHO, and other regulatory guidelines. Participate in regulatory audits and inspections related to technology transfer activities. Cross-Functional CoordinationAct as a technical liaison between R&D and manufacturing teams. Support regulatory submissions by providing technical data and responses. Collaborate with supply chain and procurement for raw material and process readiness. Qualifications B. Pharm / M. Pharm Additional Notes Technical Skills&Knowledge Strong understanding of pharmaceutical formulation processes (OSD preferred). Knowledge of scale-up principles, validation, and GMP documentation. Familiarity with regulatory expectations for tech transfer. Basic understanding of QbD, risk assessment (FMEA) is an advantage.Behavioural&Soft Skills Good communication and coordination skills Strong documentation and analytical abilities Problem-solving mindset Ability to work in cross-functional teams Preferred Skills (Optional) Experience with regulated markets (US/EU) Exposure to new product introduction (NPI)Knowledge of Lean / Six Sigma tools
Highlights
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Company namerubicon research limited
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Job positionExecutive
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