Janssen India, the pharmaceutical division of Johnson & Johnson India, is dedicated to addressing and solving some of the most important unmet medical needs of our time in India, in oncology, immunology, neuroscience and analgesia, dermatology, infectious diseases and metabolic diseases. Driven by a strong dedication to the health and well-being of patients, Janssen India brings innovative products, services and solutions to people throughout the world.
Post : Scientist
Job Description
• Preparation of technical documents e.g. not limited to stability reports, method transfer and method validation protocol and reports, Global change control, procedures, test methods, product specifications, etc.
• Review of analytical data for accuracy, compliance to quality requirements and completeness e.g. lab notebooks, raw data, LIMS entries, technical reports, etc.
• Review of technical documents such as analytical reports, method transfer /method validation protocols, reports, etc as required.
• Connect with internal groups, Global cross functional partners for collating all information and documents required for preparing technical documentation.
• Responsibilities related to laboratory processes, calibration and other related activities.
• Excellent technical writing skills: Drafting, articulation, correctness of language, word/excel/power point formatting and use of appropriate features
• Adequate knowledge related to chemistry, analytical techniques, stability study assessment and research technologies
• Deep knowledge of GMP, quality systems, SOPs, latest regulatory trends, and global regulations as appropriate and documentation practices
• Technical skills related to data review, interpretation of analytical data and accurate documentation of laboratory investigations, NC and CAPA, change control, impact assessments, etc.
• Ability to prioritize work and change focus quickly.
• Ability to connect with cross functions and global partners and collate information.
• Attention to detail and diligence.
• Excellent oral and written communication skills
• Systematic approach and commitment to assigned deliverables
Candidate Profile
• Minimum 4 years to 8 years (Prior work experience in Analytical function preferred)
• Minimum MSc, B Pharm, M.Pharm
• MS office
Additional Information
Experience : 4 years
Qualification : MSc, B.Pharm, M.Pharm
Location : Maharashtra - Greater Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 20th June, 2021
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