- 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 Product Quality Review (PQRs) for own production products and ensures its timely approval.
Preparation and review of other documents related to PQRs.
Requesting, follow-up and tracking of PQR related data.
- Review of Externally supplied PQRs, related coordination and follow up with vendor and and other stakeholders
- Theoretical evaluation of physico-chemical properties of the drug products and/or raw materials
- Co-operation with other departments/ partners
- Local in-licensing support
- To assist the overall working of Indian Pharmaceutical team
- Other possible tasks appointed by Supervisors
- Note: We do not have own laboratories in India!