Executive - Analytical

• The role will have the following responsibilities:
• 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 organizations (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 other stakeholders
• Theoretical evaluation of physio-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!
  

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