Senior Executive Pharmaceuticals Lead

3 weeks ago

Mumbai, Maharashtra, India Lifelancer Full time

About the Job

FinOrion Pharma India Pvt. Ltd. is seeking an Executive / Sr. Executive Pharmaceuticals to join their Pharmaceutical department in Mumbai. As a key member of the team, you will be responsible for ensuring the timely approval of Product Quality Review (PQRs) for own production products.

Key Responsibilities:

  • Preparation and review of documents related to PQRs
  • Requesting follow-up and tracking of PQR-related data
  • Review of externally supplied PQRs and coordination with vendors and stakeholders
  • Reviewing and commenting on change controls, deviations, temperature excursions, stability data, process validation documents, and troubleshooting for ESO products
  • Evaluation of dossiers and suggesting additional requirements for probable new markets
  • Planning and coordination of stability studies, writing and/or review of stability protocols, reports, and preparation of technical documents in CTD format
  • Coordinate and follow up stability studies at CROs/CQC
  • Writing and/or reviewing of process validation technology transfer study batch documentation for own products
  • Preparing and maintaining lists/documents/records and archiving at appropriate places
  • Coordination with other departments/partners
  • Achieving responsibilities within agreed timelines
  • Assisting the overall working of the Indian Pharmaceutical team

Description of Unit

FinOrion Pharma India Pvt. Ltd. is a wholly-owned subsidiary of Orion Group, providing an opportunity for Orion Group to strengthen business relationships with current partners and support the headquarter 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 India's office, 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 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 3000 professionals in different countries. In Finland, Orion is the leading company as a manufacturer and marketer as well as in R&D of pharmaceuticals. With strong engagement in the promotion of healthcare, Orion has been building wellbeing for more than 100 years.

We Offer

  • An excellent opportunity to work in an inspiring and important role in the area of Pharmaceuticals
  • A great opportunity to become part of the wholly-owned subsidiary of globally operating Orion Group
  • The possibility to utilize your own strengths with the support of professionals
  • A flexible, high-spirited working environment where your skills are appreciated
  • A hybrid work policy (In a week, 3 days work from office and flexibility to work remotely for two times)
  • A good work-life balance
  • Clear and transparent processes and responsible supervisors are our benefits to the personnel

Requirements

  • Bachelor's/Master's degree in Pharmacy from a reputed College/University
  • Minimum 4 years of experience in formulation R&D activities in global pharmaceutical 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

Lifelancer is a talent hiring platform in Life Sciences, Pharma, and IT. The platform connects talent with opportunities in pharma, 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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