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Executive- Analytical

3 weeks ago

Mumbai Maharashtra, India Orion Corporation Full time

**Roles and Responsibilities**
- Coordinate and follow-up with internal and external partner to review and evaluate Nitrosamine impurity and ensuring compliance to relevant guidelines.
- Managing and developing the process for Excipient GMP risk evaluation including maintenance of the structure with functionalities.
- Review elemental impurities statement, its impact on final product and ensuring compliance.
- 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 organizations (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 ensure 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
**Primary Skills (Essential)**
- Minimum 4 years' work experience in Analytical Development or Pharmaceutical product development or Quality Assurance activities in global Pharma industry
- Knowledge of EU and US requirements and ICH guidelines
- Practical development skills from the laboratory work and troubleshooting
- Task oriented with learning attitude and Teamwork skills
- Fluency in oral and written English
- Confirmed skills of Microsoft Office is essential
- Pharmaceutical education & practical analytical development skills also from the laboratory to production scale of different types of formulations (tablets, capsules, liquids, etc.) will have added advantage

**This Job offers**
- An excellent opportunity to work in an inspiring and important role in the area of Pharmaceuticals
- Great opportunity to become part of the wholly owned subsidiary of globally operating Orion Group
- Possibility to utilize your own strengths with the support of the professionals
- Flexible, high spirit working environment where your skills are appreciated
- Good work-life balance
- Clear, transparent processes and responsible supervisors are our benefits to the personnel

**Education**
- Master's degree in chemistry from a reputed College / University

At Orion, your work creates true impact and well-being for our customers, patients and society at large. Our culture of friendliness, respect, mutual appreciation and diversity creates a safe working environment where you can strive for excellence. We offer a wealth of career paths and development opportunities that support the development of innovative solutions and improving the quality of life.
- Required documents: CV/Resume
- Application deadline: 05.07.2025