Specialist - Analytical

Orion Pharma; Hyderabad; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Orion Pharma in Hyderabad, India, seeks a stability studies specialist to plan, write, and review stability protocols and CTD-formatted documents. You will coordinate stability studies at CROs and Orion's CQC lab, and support validation and method transfer activities.

You'll evaluate validation protocols, review PQRs for own production and externally supplied products, and ensure regulatory compliance while collaborating across departments. Note: there are no in-house labs in India.

Qualifications

• Experience coordinating stability studies with CROs/CQC in India.
• Proficient in preparing CTD-formatted regulatory documents.
• Reviewing validation protocols and external analytical methods.
• Handling PQRs for own production and externally supplied products.

Responsibilities

• Plan and coordinate stability studies at CROs/CQC.
• Write/check CTD documents and ensure regulatory compliance.
• Evaluate method validation protocols/reports from CROs.
• Review change controls, deviations, and stability data.
• Prepare and review PQRs for internal and external products.

Skills

Stability studies planning

Documentation writing

Regulatory compliance

CRO coordination

Analytical method validation

PQR preparation

Quality systems

Cross-functional collaboration

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.