Orion Pharma has announced an opening for Specialist – Analytical in India, with positions based in Mumbai and Hyderabad under a hybrid work model. The role focuses on analytical documentation, stability studies, method validation and transfer, Product Quality Reviews (PQRs), CTD documentation, CRO coordination and pharmaceutical quality activities.
This opportunity is particularly relevant to professionals working in analytical affairs, pharmaceutical quality, analytical development, regulatory documentation and lifecycle management.
Orion is a globally operating Nordic pharmaceutical company involved in developing, manufacturing and marketing human and veterinary pharmaceuticals and active pharmaceutical ingredients. Its official India locations include offices in Mumbai and Hyderabad.
Job Overview
| Details | Information |
|---|---|
| Company | Orion Pharma |
| Job Title | Specialist – Analytical |
| Job ID | 1788 |
| Location | Mumbai & Hyderabad |
| Work Mode | Hybrid |
| Employment Type | Full Time |
| Job Category | Commercial Product Development & Lifecycle Management |
| Posting Date | 18 September 2026 |
| Application Deadline | 19 October 2026 |
| Salary | Not disclosed by Orion |
Key Responsibilities
The selected candidate will support analytical and pharmaceutical activities for Orion’s Indian Pharmaceutical team.
Stability Studies & Documentation
- Plan and coordinate stability studies.
- Prepare and review stability protocols and reports.
- Prepare technical documentation in CTD format.
- Coordinate stability activities with CROs and Orion’s Chemical Quality Control laboratory partners.
- Review stability data and provide appropriate technical comments.
Analytical Method Validation & Transfer
- Coordinate analytical method validation activities with CROs.
- Follow up on analytical method transfer activities.
- Evaluate method validation protocols and reports.
- Review analytical methods and associated technical documentation.
- Support troubleshooting related to analytical activities.
Regulatory & Quality Documentation
- Prepare, check and review analytical and pharmaceutical documents according to regulatory requirements.
- Support preparation of method and validation documents.
- Contribute to variations and responses to additional regulatory questions.
- Review change controls, deviations and temperature excursions.
- Review process validation documentation for externally supplied products.
Product Quality Review (PQR)
- Prepare Product Quality Reviews (PQRs) for applicable production products.
- Ensure PQR documents are completed and approved on time.
- Prepare and review documents associated with PQRs.
- Request, track and follow up on PQR-related information.
- Review PQRs received from external suppliers.
- Coordinate with vendors and internal stakeholders regarding PQR requirements.
Technical & Cross-Functional Support
- Evaluate the theoretical physicochemical properties of drug products and raw materials.
- Prepare analytical methods and related documents within Orion’s IT systems.
- Support local in-licensing activities.
- Work collaboratively with other departments and external partners.
- Support the overall activities of the Indian Pharmaceutical team.
- Perform additional responsibilities assigned by supervisors.
Important: The supplied job description states that Orion does not have its own laboratories in India, so the position involves significant coordination with external laboratories, CROs and other partners.
Qualifications
The supplied vacancy description does not explicitly state a mandatory educational qualification. Based on the analytical, pharmaceutical documentation and quality responsibilities of the position, relevant academic backgrounds would typically include:
- M.Pharm – Pharmaceutical Analysis / Quality Assurance / Pharmaceutics or related specialization
- B.Pharm
- M.Sc. – Analytical Chemistry / Pharmaceutical Chemistry / Chemistry
- Other closely related pharmaceutical or analytical-science qualifications may be relevant depending on Orion’s screening criteria.
Candidates should carefully check the official vacancy requirements before applying.
A previous Orion analytical-related vacancy in India has also listed Pharmacy, Analytical Chemistry, Pharmaceutical Sciences and related Life Sciences backgrounds for analytical affairs work.
Relevant Skills
Analytical Method Validation | Method Transfer | Stability Studies | CTD Documentation | PQR | Pharmaceutical Quality | CRO Coordination | Change Control | Deviation Management | Regulatory Documentation | Analytical Chemistry | ICH Guidelines | Technical Writing | Vendor Management
Who Can Apply?
This position is particularly relevant to professionals with experience or knowledge in areas such as:
- Analytical Development
- Analytical Affairs
- Pharmaceutical Analysis
- Quality Assurance
- Quality Control
- Stability Management
- Method Validation
- Method Transfer
- Pharmaceutical Regulatory Documentation
- CMC Documentation
- Product Quality Review
- CRO Management
Candidates with practical experience in pharmaceutical documentation, stability studies, analytical methods and quality systems should review the complete Orion requirements before submitting an application.
Work Location
The position is available in:
Mumbai: Smartworks Coworking Location, Times Square Building, Andheri Marol, Andheri East, Mumbai – 400059.
Hyderabad: Smartworks Coworking Spaces, Hyderabad Knowledge City, Telangana – 500081.
How to Apply
