Specialist - Analytical

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!