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Solid orals & Injectables (TT) - Executive To Senior Executive

4 - 8 years

6 - 10 Lacs

Hyderabad

Posted:2 days ago| Platform: Naukri logo

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Skills Required

Scale Up Risk Assessment Bmr Technology Transfer Sampling Solid Orals reports Protocols Bpr Exhibit Batches Injectables

Work Mode

Work from Office

Job Type

Full Time

Job Description

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.

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Cronus Pharma
Cronus Pharma
www.cronuspharma.com

Biopharmaceuticals

San Diego

150 Employees

6 Jobs

    Key People

  • Dr. Emily Chen

    CEO

  • John Doe

    Chief Financial Officer

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