Pharmaceuticals Executive
6 days ago
About the Job
FinOrion Pharma India Pvt.Ltd. is seeking an experienced professional to fill the role of Executive / Sr. Executive Pharmaceuticals in the Pharmaceuticals department. The successful candidate will be based in Mumbai and will be responsible for ensuring the timely approval of Product Quality Review (PQRs) for own production products.
Key Responsibilities:
- Writing and reviewing of PQRs, ensuring compliance with regulatory requirements.
- Preparation and review of other documents related to PQRs.
- Requesting follow-up and tracking of PQR-related data.
- Review of externally supplied PQRs, coordinating with vendors and other stakeholders.
- Reviewing and commenting on change controls, deviations, temperature excursions, stability data, process validation documents, and troubleshooting for ESO products.
- Evaluating dossiers and suggesting additional requirements for probable new markets.
- Planning and executing stability studies, writing and/or reviewing stability protocols, reports, and preparation of technical documents in CTD format.
- Coordinating and following up on stability studies at CROs/CQC.
- Writing and/or reviewing process validation, technology transfer study batch documentation for own products.
- Preparing and maintaining lists, documents, records, and archiving at appropriate places.
- Coordinating with other departments and partners.
- Achieving responsibilities within agreed timelines.
- Assisting the overall working of the Indian Pharmaceutical team.
- Other tasks appointed by supervisors.
Description of Unit
FinOrion Pharma India Pvt. Ltd. is a wholly owned subsidiary of Orion Group. The India office focuses on Global Operations and R&D activities, including procurement, packaging technology, quality assurance, and product life cycle management.
Orion Corporation is a globally operating Finnish company that develops, manufactures, and markets human and veterinary pharmaceuticals, active pharmaceutical ingredients, and offers a range of benefits to its personnel, including a flexible work environment, hybrid work policy, and good work-life balance.
Requirements
- Bachelor's/Master's degree in Pharmacy from a reputed College/University.
- Minimum 4 years of experience in formulation R&D activities in the global pharmaceutical industry.
- Confirmed knowledge of EU requirements and ICH guidelines.
- Candidate with interest and/or experience in pharmaceutical documentation or relevant pharmaceutical formulation/manufacturing documentation will be preferred.
- Practical development skills from laboratory to production scale concerning diverse types of formulations will be considered as an added advantage.
- Proactiveness and problem-solving abilities.
- Fluency in oral and written English.
- Task-oriented with learning attitude and teamwork skills.
- Confirmed skills of Microsoft Office are essential.
Lifelancer is a talent hiring platform in Life Sciences, Pharma, and IT. The platform connects talent with opportunities in biotech, health sciences, healthtech, data science, and IT domains.
Please use the below Lifelancer link for job application and quicker response.
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Remote Work: No
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