Expert Science & Technology (Oral Solid Dosage forms)

5 - 9 years

0 Lacs

Posted:2 days ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

Role Overview: You will be responsible for performing and documenting scientific experiments in the laboratory for drug substances (DS) and drug products (DP) in collaboration with multifunctional project teams. Your key role will be to contribute to the maintenance of lab instruments and day-to-day operations to ensure timely execution of project-related activities supporting TRD-NCE strategies and goals. Key Responsibilities: - Plan, organize, execute, and document scientific experiments such as analytical method developments/validations/transfers/stability/release testing, and formulation development analytics according to agreed timelines and quality standards. - Accountable for documenting and submitting raw data in the appropriate data system, such as LIMS test activation and results entry. - Ensure good documentation practices (GDP) and good laboratory practices (GLP) are followed during the execution of laboratory activities. - Support in the evaluation and interpretation of results, including investigations on SST failures, OOX/Deviations/Change controls as needed. - Manage assigned laboratory-related areas/activities, including chemical/reagents/consumables/samples/column/glassware management. - Implement and maintain lean/efficient/environmentally sustainable practices in the laboratory. - Communicate key issues and critical topics proactively and in a timely manner to the manager and/or relevant project team member(s). - Meet Key Quality Indicators (KQI) and Key Performance Indicators (KPI) for all assigned activities. - Support internal and external audits, ensuring no critical findings within the assigned scope. - Actively contribute to team and organization goals by working according to appropriate SOPs, GMP, GLP, QM, HSE, ISRM & Novartis Guidelines. Qualifications Required: - Masters in Life Science (e.g., analytical/organic chemistry/pharmacy/pharmaceutical development) or equivalent. - Minimum 5 years of relevant work experience in OSD forms, with hands-on experience in chromatography, multimedia dissolutions, In-vivo & Invitro dissolutions, quality investigations, QBD, etc. - Fluency in English (oral and written) and knowledge of site language if required. - Knowledge in quality principles driving drug development such as GMP. - Understanding of general regulatory and quality expectations. - Good scientific background, communication skills including presentation and scientific/technical writing. Note: The job description does not contain any additional details about the company.,

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