Solid orals & Injectables (TTD) - Executive To Asst. Manager

Role & responsibilities

Job description

• Dosage forms experience: Solid Oral & Injectable experience in TTD/PDL/MS&T.
• Perform formulation development activities on differentiated formulations and innovative technologies as part of product development in R&D and in Pilot/Manufacturing Site.
• Follow good laboratory practices, good documentation practices (LNB writing) and maintain the logbooks and forms for equipment/instruments.
• Dedicate Experience in technology transfer of product(s) under development activities from scale up, exhibit batches.
• To lead and support the site transfer products from scale up to product launch.
• To prepare, review and hand-over the Technology Transfer Dossier to plant and communicating effectively to CFT team :-
• MFR, MPR, BMR, BPR,
• Preliminary Risk assessment (as per QbD)
• Risk Assessment of before going to Scaleup
• Risk Assessment of before going to Exhibit batches
• Scaleup Protocol & reports
• Scaleup Sampling and Exhibit batch sampling Plan
• Exhibit batch reports
• Control Strategy (Qbd) before Scaleup, Exhibit batches
• Risk assessment of CPP over CQAs and etc.

And not limited to.

• To provide the technical inputs for initiation of Scale up batches.
• To provide the technical presentation on new product initiation to Cross functional team.
• To monitoring and execution of Scale up batches for site transfer products as well as in-house developed products.
• To co-ordinate with cross functional teams for smooth technology transfer.
• To review the exhibit batch documents, intended documents for filing purpose.

Qualifications

• M.Pharm or Ph.D. in Pharmacy with minimum industrial experience of 4 to 9 years in technology transfer solid oral formulations and injectable products.