Job Description
Job Description
- Responsible for planning stability studies, writing and/or review of stability protocols, reports, and preparation of technical documents in CTD format.
- Co-ordinate and follow up stability studies at contract research organisations (CROs)/ Chemical Quality Control lab of Orion (CQC).
- Co-ordinate and follow up validation and method transfer at CROs.
- Write/check/review analytical and pharmaceutical documents as per regulatory requirements (method and validation documents/ variations/ additional question responses)
- Evaluate/ review method validation protocols / reports / analytical methods prepared by CROs.
- Reviewing and commenting on change controls, deviations, temperature excursions, stability data, process validation documents and troubleshooting, etc. for externally supplied products.
- Write documents into Orion's IT systems for example analytical methods
- Writing of...
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