Executive – Analytical
Job ID: 976
Location: Mumbai, India & Hyderabad, India (Hybrid)
Employment Type: Full-Time
Company Overview:
Orion Pharma is a globally recognized Nordic pharmaceutical company with over a century of experience in building well-being. With more than 4,000 employees worldwide, Orion Pharma is committed to scientific excellence, innovation, and creating a collaborative work culture where employees are valued, trusted, and supported. The company develops, manufactures, and markets human and veterinary pharmaceuticals, active pharmaceutical ingredients, and consumer health products. Core therapy areas include oncology, pain management, neurological, respiratory, and other therapeutic domains.
Position Summary:
The Executive – Analytical will play a key role in the planning, execution, and coordination of analytical and stability studies, ensuring compliance with global regulatory standards and Orion’s quality policies. This position involves collaboration with contract research organizations (CROs) and internal teams, supporting the overall operations of the Indian pharmaceutical team.
Key Responsibilities:
Plan, write, and review stability study protocols, reports, and related technical documents in CTD format.
Coordinate and follow up on stability studies at CROs and Orion’s Chemical Quality Control (CQC) lab.
Manage validation studies and method transfers with CROs.
Prepare, review, and approve analytical and pharmaceutical documents in compliance with regulatory requirements (method validation documents, variations, and responses to queries).
Evaluate and review method validation protocols, reports, and analytical methods prepared by CROs.
Review and provide feedback on change controls, deviations, temperature excursions, stability data, and process validation documents.
Input analytical methods and related documents into Orion’s IT systems.
Prepare and review Product Quality Reviews (PQRs) for both internal and externally supplied products, ensuring timely approval.
Track and follow up on PQR-related data and coordinate with vendors and stakeholders.
Perform theoretical evaluation of physicochemical properties of drug products and raw materials.
Support local in-licensing activities and collaboration with other departments.
Undertake other tasks as assigned by supervisors.
Experience & Requirements:
Minimum 1–3 years of experience in analytical development, quality control, or pharmaceutical documentation.
Experience coordinating stability studies and method validation with CROs.
Knowledge of CTD documentation, analytical method validation, and regulatory compliance.
Strong understanding of pharmaceutical quality systems, deviations, change controls, and PQRs.
Excellent communication and cross-functional collaboration skills.
Proficiency in English (written and spoken).
Why Orion Pharma:
At Orion Pharma, you will join a culture that values innovation, excellence, and collaboration. Employees are empowered to grow professionally while contributing to meaningful work that improves patient outcomes globally. Orion Pharma provides opportunities to develop a career in pharmaceutical R&D, analytical sciences, and quality assurance, with a clear focus on personal and professional development.
Location Details:
Mumbai: Smartworks Coworking Location – Times Square Building, 9th Floor, C Wing, Andheri Marol, Andheri East, Mumbai, 400059
Hyderabad (Hybrid): Smartworks Coworking Spaces, Hyderabad, 500081
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