| 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 |
| Industry Type | Pharma/ Biotech/Clinical Research |
| Role | Other |
| Functional Area | Other |
| Education | UG - Any Graduate - Any Specialization PG - Any PG Course - Any Specialization |
| Location | Hyderabad / Secunderabad |
| Keywords | Freshers |
| Contact | Mr/Ms Novartis Healthcare Pvt Ltd |
| Website | http://www.novartis.com/ Click Here |
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