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Executive / Sr. Executive - Pharmaceuticals

Orion Corporation
Mumbai, Maharashtra
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6 days agoFull–time
Position: Executive / Sr. Executive - Pharmaceuticals

Company: FinOrion Pharma India Pvt. Ltd.

Department: Pharmaceuticals

FinOrion Pharma India is looking for an Executive / Sr. Executive - Pharmaceuticals in Pharmaceuticals department. In this position you will be based in Mumbai.

Description Of Position

Responsibilities in this role:
• 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.
• 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.
• 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

Note: We do not have own laboratories in India!