job title: Executive - Analytical(Orion pharma)

Roles and Responsibilities

• 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