Specialist - Analytical

Orion Pharma; Mumbai; On-site; INR 700,000 - 1,100,000; Full time

Job summary

Orion Pharma in Mumbai is seeking a stability studies specialist to lead planning, protocol and report writing in CTD format, ensuring regulatory compliance and timely documentation.

You will coordinate stability studies with CROs and Orion's CQC lab, assist with method validation and transfer, and contribute to PQR development and approvals within a collaborative Indian team.

Responsibilities

• Plan stability studies and prepare CTD-formatted protocols and reports.
• Coordinate stability studies at CROs and Orion CQC laboratory.
• Coordinate validation and method transfer at CROs.
• Write/check/review analytical and pharmaceutical documents per regulatory requirements.
• Evaluate/review method validation protocols/reports/analytical methods by CROs.
• Review change controls, deviations, temperature excursions, stability data, and process validation docs for externally supplied products.
• Write documents into Orion’s IT systems (e.g., analytical methods).
• Prepare and review Product Quality Reviews (PQRs) for own production products and ensure timely approval.
• Request, follow-up and track PQR-related data.
• Review externally supplied PQRs and coordinate with vendors and stakeholders.
• Theoretical evaluation of physico-chemical properties of drug products and/or raw materials.
• Co-operate with other departments/partners.
• Local in-licensing support.
• Assist the Indian Pharmaceutical team in overall operations.
• Other tasks as assigned by Supervisors.
• Note: Orion does not have own laboratories in India!

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 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!

About Us

Orion Pharma is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years.

We’re home to more than 4,000 Orionees around the world, and we’re proud to be known as a responsible employer and a great place to work. At Orion Pharma, people are truly valued and trusted, encouraged to grow, and supported by a culture where every voice is heard. We appreciate each other, strive for excellence, and build the future.

Together we develop, manufacture, and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Our extensive portfolio includes proprietary and generic medicines as well as consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion Pharma are used to treat cancer, neurological diseases, respiratory diseases, and more.

We offer careers with a clear purpose: empowering people to live their lives to the fullest.