Executive to AM-ARD
0 - 5 Years of ExperienceNot disclosed Full Time
Penam Biosciences Private Limited
Jammu, Jammu and Kashmir, India
Posted on 27-12-2024
8 Views
1 Vacancy
Description
- Develop, validate, and document analytical methods for raw materials, in-process samples, and finished products.
- Conduct stability studies, impurity profiling, and degradation studies in compliance with regulatory guidelines.
- Troubleshoot and resolve analytical challenges during the development and scale-up phases of product development.
- Prepare and review protocols, validation reports, and technical documentation for regulatory submissions.
- Perform routine and advanced analytical testing using instruments like HPLC, GC, LC-MS, UV, FTIR, etc.
- Ensure compliance with GMP, GLP, ICH guidelines, and other regulatory requirements in all ARD activities.
- Collaborate with cross-functional teams, including R&D, Quality Assurance, and Regulatory Affairs, to support product development.
- Manage laboratory equipment, ensuring proper calibration, maintenance, and qualification.
- Supervise and mentor junior team members, fostering a culture of quality, accuracy, and innovation.
Category
Pharmaceuticals
Key Skills
CommunicationAttention to DetailDecision MakingPositive Attitude
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