Novartis Healthcare Pvt Ltd
Hyderabad
Freshers
Job Description
Support timely preparation of high quality drug substance and/or drug product Quality (CMC) documentation, to support global regulatory submissions
Prepare CMC responses to health authority questions, during development, registration, and product lifecycle
Identify the required documentation for submissions and negotiate the delivery of approved technical source documents in accordance with project timelines
Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects Support to compliance activities
The major activities would be to :
QC the registration documents according to appropriate checklists
Support the Reg CMC teams in their document management duties
Support the electronic document management and publishing systems
Support the HAQ database management, QC checking of published dossiers
Support the Variation approval tracking, Document Administration check and DRAGON remediation
Write high-quality CMC documentation.
Desired Profile
MSc, M.Pharm, Ph.D. Fresh ((e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or upto 2 years experience
Experience 0 - 2 Years
Education UG - Any Graduate - Any Specialization, PG - Any PG Course - Any Specialization
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