Job Title: Executive – Analytical
Location: Mumbai, India & Hyderabad, India (Hybrid)
Experience Required: 2–5 Years
Job Type: Full-Time
Job ID: 976
Orion Pharma, a leading global pharmaceutical company, is seeking a dedicated Executive – Analytical to join our Indian Pharmaceutical team. This role is ideal for professionals with experience in analytical operations, stability studies, and regulatory documentation, contributing to the quality and compliance of pharmaceutical products.
Key Responsibilities:
Plan, coordinate, and monitor stability studies, including writing and reviewing stability protocols and reports.
Prepare and manage technical documents in CTD format for regulatory submissions.
Liaise with Contract Research Organizations (CROs) and Orion’s Chemical Quality Control (CQC) labs to follow up on stability studies, method validation, and method transfers.
Review and evaluate analytical methods, validation protocols, and reports prepared by CROs.
Assess and comment on change controls, deviations, temperature excursions, process validation documents, and troubleshooting for externally supplied products.
Prepare and enter analytical documentation into Orion’s IT systems, ensuring compliance with internal and regulatory standards.
Write and review Product Quality Reviews (PQRs) for both internal and externally supplied products, coordinating with vendors and stakeholders.
Conduct theoretical evaluation of physicochemical properties of drug products and raw materials.
Collaborate with cross-functional teams, internal departments, and external partners to support regulatory and operational objectives.
Provide local support for in-licensing and other pharmaceutical activities in India.
Execute additional tasks and responsibilities as assigned by supervisors.
Note: Orion Pharma does not operate its own laboratories in India; this role focuses on coordination, documentation, and compliance activities.
Bachelor’s or Master’s degree in Pharmacy, Chemistry, or Life Sciences.
2–5 years of experience in analytical development, stability studies, and regulatory documentation within the pharmaceutical industry.
Strong understanding of analytical method validation, stability testing, and regulatory requirements.
Excellent skills in technical writing, documentation, and report review.
Ability to coordinate effectively with CROs, vendors, and cross-functional teams.
Strong analytical and problem-solving skills, attention to detail, and ability to work in a hybrid setup.
Proficiency in IT systems for documentation and regulatory submissions.
Orion Pharma is a Nordic pharmaceutical company with over 100 years of experience in building well-being worldwide. With a workforce of over 4,000 employees, we develop, manufacture, and market human and veterinary pharmaceuticals, active pharmaceutical ingredients (APIs), and consumer health products. Our core therapeutic areas include oncology, neurology, respiratory diseases, and pain management.
At Orion, we foster a culture where employees are valued, trusted, and encouraged to grow, with opportunities to make meaningful contributions to global healthcare.
Locations:
Smartworks Coworking – Times Square Building, 9th Floor, C Wing, Andheri Marol, Andheri East, Mumbai, 400059, India
Smartworks Coworking Spaces, Hyderabad, 500081, India (Hybrid)
Apply Now: Submit your resume to join a global leader in pharmaceutical innovation and quality.
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