Posted:2 days ago|
Platform:
On-site
Full Time
Execution of product development stage experimental activities ( API chracterisation, Preformulation studies, formulation and process development , stability studies, Packaging evaluations, scaleup and dossier batches activities ) Follow and ensure compliance to Good documentation , cGMP & regulatory requirements for Formulation activities at in house Formulation Development facility. Executing experiments as per project requirements and timelines Qualification & Calibration activities. Preparation of System and Equipment related SOP's. Working on Technical documentation & Protocols for executions. Establishing In-house systems and procedures to ensure cGMP practices & regulatory requirements. Submission and handling of analytical samples. Any other specific functional activities defined on case to case basis. Preparation, documentation and followups for the approval of lab scale related activites.
Literature search & Summary Execution of product development experimental acitivities as defined. Prior experience in Formulation development of generic drug products intended for Regulatoery markets, preferably EU market. Strong technical skills in formulation development and trouble shooting in formulation development. Good communication and willing travel. Assisting in Qualification of instruments. Calibration of instruments as per the schedule. Preparation of System and Equipment related SOP's. Submission of samples to analytical, collecting the reports and compile the data for review and discussions. Development data compilations Project requirement assessments for executions. Following in-house systems and procedures to ensure cGMP practices & regulatory requirements Maintenance of Equipment /Calibration /development activities. Raise the Purchase requisition for procurement of any material related to project execution activities General Laboratory monitoring and maintenance activity as applicable.
Formal qualification needed: B.PHARMA , B SC,M SC.B.TEC
Job Type: Full-time
Pay: From ₹15,000.00 per month
Work Location: In person
PREM GREEN PVT.LTD.
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