Analytical CMC documentation Role at Orion Pharma

Orion Pharma, a globally reputed Nordic pharmaceutical company, is hiring an Executive – Analytical for its Indian Pharmaceutical team. This hybrid job opportunity in Mumbai and Hyderabad is ideal for professionals with experience in analytical documentation, stability studies, CTD submissions, CRO coordination, and Product Quality Reviews (PQRs).

With no in-house laboratories in India, this role offers strong exposure to global regulatory practices, CRO management, and international quality systems, making it a highly valuable career move for analytical and regulatory professionals.

Job Overview

• Position: Executive – Analytical
• Company: Orion Pharma
• Job ID: 1104
• Job Type: Full Time | Hybrid
• Locations:
  • Mumbai – Andheri East (Smartworks Coworking)
  • Hyderabad – Smartworks Coworking Spaces
• Date Posted: 05 January 2026

Key Responsibilities – Executive Analytical Role

• Plan and manage stability studies, including protocol and report preparation
• Write, review, and compile CTD-format technical documents
• Coordinate and follow up stability studies at CROs and Orion CQC labs
• Manage method transfer and analytical validation at CROs
• Review analytical methods, validation protocols, and reports
• Prepare responses for regulatory variations and deficiency queries
• Review change controls, deviations, OOS, temperature excursions, and stability data
• Author and manage analytical methods in Orion IT systems
• Prepare and review Product Quality Reviews (PQRs)
• Track and coordinate PQR data with vendors and stakeholders
• Review externally supplied PQRs and ensure compliance
• Perform theoretical evaluation of physico-chemical properties of drug products and raw materials
• Support local in-licensing activities
• Collaborate with cross-functional and global teams

Required Qualifications & Skills

• M.Pharm / MSc (Analytical Chemistry, Pharmaceutical Sciences or related field)
• Experience in analytical documentation, stability studies, and regulatory submissions
• Strong understanding of ICH, EU, and global regulatory guidelines
• Experience working with CROs and external laboratories
• Hands-on knowledge of CTD modules, method validation, and PQRs
• Excellent documentation, coordination, and communication skills

Why Join Orion Pharma?

• Work with a 100+ year global pharmaceutical leader
• Strong exposure to international regulatory and quality systems
• Hybrid working model for better work–life balance
• Inclusive culture where expertise and accountability are valued
• Long-term career growth in analytical and regulatory affairs

Salary & Compensation

• Estimated Salary Range: ₹8,00,000 – ₹12,00,000 per annum
  (Final compensation will depend on experience and qualifications)

How to Apply

Application Link