Presently working as Research associate
Published on: Mar 4, 2016
Transcripts - Presently working as Research associate
Presently working as Research associate, Analytical R & D (Q. A.) & involved in following
1. Review and ensure compliance of Analytical Validation protocols, LNBs and raw data for
Parenteral dosage forms for regulated markets.
2. Preparation of documents as per the regulatory requirements such as specifications,
standard test procedures, standard operating procedures etc.
3. Preparation and review of SOPs and guidelines used in R & D.
4. Review of stability data generated for both Regulatory and Domestic commercial release
5. Review and ensure compliance of Analytical Validation protocols, LNBs and raw data for
various dosage forms for regulated and ROW markets.
6. Preparation of the documents to be submitted to various regulatory authorities.
7. Co-ordination with strategic heads from different location for documents required to
Regulatory department for submission of dossier to Regulatory Authorities.
8 Data review of stability studies for all formulations and products under development
at R & D in various storage conditions.
9. Ensuring the proper and timely completion of Installation, calibration and preventive
maintenance of all analytical instruments.
10. Issue and control of method development protocols, Laboratory note books, calibration
work records, working standard analysis work records, Analytical method validation work
records, Instrument Logbooks etc.
11. Issuance and maintenance of Incident reports and change controls.
12. Review and ensure compliance of Analytical method transfer
protocols, analytical work records and raw data for various dosage forms for regulated