Executive- Analytical

Roles and Responsibilities

• 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
• Candidate interested/experienced in above documentation work will be preferred.

• 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

• Please fill Candidate Information Form on https: / / forms.gle / o9BhfmhigBcyp5fy7 & email your CV to recruitmentindia@orion.fi
• Required documents: CV/Resume
• Application deadline: 18.07.2025