Job Description

About the jobFinOrion Pharma India Pvt. Ltd. is looking for an Executive / Sr. Executive - Pharmaceuticals in Pharmaceuticals department. In this position you will be based in Mumbai.Description Of PositionResponsibilities:

• Writing of Product Quality Review (PQRs) for own production products 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 other stakeholders.
• Reviewing and commenting on change controls, deviations, temperature excursions, stability data, process validation documents, troubleshooting etc. for ESO products.
• To evaluate dossiers and suggest the additional requirements (if any) for probable new market.
• 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 Orions 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 tasks appointed by Supervisors
• Note: We do not have own laboratories in India!

Description Of UnitFinOrion Pharma India Pvt. Ltd. ( ) is a wholly owned subsidiary of Orion Group. A presence in India provides an opportunity for Orion Group to strengthen the business relationship with the current partners and support the head quarter in various office activities. The India office focuses mainly on Global Operations and R D activities.Global Operations is one of the core areas of operations in Orion\'s India office. This office is involved in procurement of in-licensed formulated products and pharmaceutical ingredients for in-house manufacturing in Finland. The Packaging Technology team is involved in creating and managing artworks for both in-licensed and in-house manufactured products. The Quality assurance team is involved in auditing our partners globally for ensuring cGMP compliance.CPD LCM India (Pharmaceuticals and Regulatory Affairs teams) supports the product life cycle management, maintenance of marketing authorizations, various other documentation requirements and supports activities such as biostatistics, programming and medical writing tasks for regulated markets. The Creative Design team in India supports digital / graphic designing activities.Orion Corporation ( ) is a globally operating Finnish company that develops, manufactures and markets human and veterinary pharmaceuticals, active pharmaceutical ingredients. The company employs more than 3,000 professionals in different countries. In Finland, Orion is the leading company as a manufacturer and marketer as well as in RD of pharmaceuticals. With strong engagement in the promotion of healthcare, Orion has been building well-being for more than 100 years. Our ambition in the far-sighted research activity is to introduce novel, innovative medicinal treatments for global markets.We offer

• 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
• Hybrid Work Policy (In a week - 3 days work from office and flexibility to work remotely for two times).
• Good work-life balance
• Clear, transparent processes and responsible supervisors are our benefits to the personnel

Requirements

• Bachelors / Master\'s degree in Pharmacy from a reputed College / University
• Minimum 4 years\' experience in Formulation RD activities in global Pharma industry
• 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 diverse types of formulations (tablets, capsules, liquids, etc.) 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 is essential

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