Roles and Responsibilities
- To perform product lifecycle management tasks for externally supplied products and own production products like evaluation of change controls, deviations, temperature excursions, stability data, process validation documents from Product quality point of view.
- Handling of problem-solving cases for products (includes both analytical and formulation related changes which have impact on product quality).
- Overall product quality evaluation and provide input during supplier's meetings.
- Follow up with suppliers and/or other stakeholders for documents related to changes for externally supplied products. E.g., possible impurities in API and finished products risk assessment in line with updated guidelines.
- Requesting, follow-up and tracking of Product Quality Review (PQRs) related data.
- Preparation and evaluation of Product Quality Review (PQRs) for externally supplied products, related coordination and follow-up with suppliers and other stakeholders.
- Writing of Product Quality Review (PQRs) for own production products and ensure its timely approval.
- Preparation and review of other documents related to Product Quality Review (PQRs).
- 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 CROs/CQC.
- Writing and/or reviewing of process validation, technology transfer, study batch documentation for own products.
- Write/check/review pharmaceutical documents as per regulatory requirements.
- Candidate having knowledge of theoretical and/or possible Physico-chemical risks for products based on appropriate available data (E.g., evaluation of synthesis route of API, excipients, packaging materials details etc.) will be an added advantage.
- Write documents into Orion’s IT systems.
- Preparation and maintenance of lists/documents/records and archiving at appropriate place.
- Co-ordination with other departments / partners.
- Achievements of responsibilities within the agreed timelines.
- 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' experience in Formulation R&D or API R&D activities in global Pharma industry
- Knowledge of organic chemistry/ Pharmaceutical medicinal chemistry/ synthetic chemistry will be an added advantage
- Ability to analyze the impact of change on Nitrosamine and/or other relevant physico-chemical risks assessment, if possible.
- Confirmed knowledge of EU requirements and ICH guidelines
- Candidate having interest and/or experience in pharmaceuticals documentation or any relevant pharmaceutical formulation / manufacturing related documentation will be preferred.
- Practical development skills from the laboratory to the production scale concerning different types of formulations (tablets, capsules, liquids, etc.) will be considered as an added advantage.
- Fluency in oral and written English
- Task oriented with learning attitude and Teamwork skills
- Confirmed skills of Microsoft Office are essential
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 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
Bachelors/master's degree in pharmacy from a reputed College/University orMaster's degree in chemistry from a reputed College/UniversityAt 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.Please visit our website to find further information about our values and Orion as an employer https://www.orion.fi/en/careers/orion-as-an-employer/ .
How To Apply And Additional Information
- Please fill Candidate Information Form on https://forms.gle/o9BhfmhigBcyp5fy7 & email your CV to recruitmentindia@orion.fi
- Required documents: CV/Resume
- Application deadline: 31.07.2025
About Us
Orion is a globally operating Finnish pharmaceutical company – a builder of well-being for over a hundred years.Orion provides meaningful work for more than 3 600 Orionees in Finland and abroad. Orion is known as a responsible and reliable employer where we value each other, strive for the best and build for tomorrow.We develop, manufacture and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Orion has an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion are used to treat cancer, neurological diseases and respiratory diseases, among others.
