Founded 4 Decades ago Alkem Laboratories is now amongst India’s largest Generic and Specialty Manufacturing Company
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Alkem has 21 Manufacturing Units in India and Across The world, and are Inspected by Worlds main Regulatory Bodies and Approved like USFDA/MHRA/TGA, etc
Position: Senior Scientist – Formulations for Domestic Market
Location: Mumbai, Maharashtra, India
Roles and Responsibilities:
- Literature review, Patent Evaluation, Pre-formulation study.
- Innovator/Market sample evaluation, Lab’s scale batches/Trials, Optimization Batches, and reporting all trial details in PDR/LMB.
- Stability study, Planning pivotal batches and conducting same in labs and plant,
- Preparation of scale-up batch & Process qualification batch documents and conducting same in-plant facility.
- Preparation of documents for DCGI filing as per DCGI guidelines for the new products.
- Preparation of Tech transfer documentation like Change Control, New product introduction, Master Manufacturing formula, Bill Of Material, and Product Development Report for the domestic market.
- Preparation and Checking of Master Manufacturing Document, MFR, Product Development Report, Process Validation Report, Process Validation Protocol, Checking feasibility parameters in the registered specification for Domestic market and conducting optimization and exhibit batches for Domestic market.
- Conducting Exhibit batches in the plant according to cGMP.
- Operating and Maintaining equipment and instruments as per SOP.
- Monitoring and maintaining the cleanliness of the department.
- System Improvement and System-related development.
Desired Candidate Profile :
- Knowledge about formulation development for Domestic Market
- Capability of converting from Lab-scale batch into Pilot-scale batch
- Knowledge of ICH/CDSCO/US-FDA/MHRA guidance
Experience: 6-8 Years
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