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Solid orals & Injectables (TT) - Executive To Senior Executive @ Cronus Pharma

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

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.

Job Classification

Industry: Pharmaceutical & Life Sciences
Functional Area / Department: Research & Development
Role Category: Research & Development - Other
Role: Research & Development - Other
Employement Type: Full time

Contact Details:

Company: Cronus Pharma
Location(s): Hyderabad

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

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Cronus Pharma

Cronus Pharma is a fast-growing, privately held pharmaceutical company located in New Jersey, dedicated to providing innovative and cost effective products to the animal health market.Cronus Pharma was Initiated Pharma specialties Project in India in May 2017 with a focus on General Injectable, Soli...