Pharmaceuticals Executive

1 month ago

Mumbai, Maharashtra, India Lifelancer Full time
About the Job

FinOrion Pharma India Pvt. Ltd. is seeking a highly skilled Executive / Sr. Executive Pharmaceuticals to join their Pharmaceuticals department in Mumbai. This role will involve working closely with the team to ensure the timely approval of Product Quality Review (PQRs) for own production products.

Responsibilities
  • Prepare and review PQRs, ensuring timely approval and coordination with vendors and stakeholders.
  • Request and track PQR-related data, ensuring compliance with regulatory requirements.
  • Review and comment on change controls, deviations, temperature excursions, stability data, process validation documents, and troubleshooting for ESO products.
  • Evaluate dossiers and suggest additional requirements for probable new markets.
  • Plan and execute stability studies, writing and/or reviewing stability protocols, reports, and technical documents in CTD format.
  • Coordinate and follow up on stability studies at CROs/CQC.
  • Write and/or review process validation technology transfer study batch documentation for own products.
  • Prepare and maintain lists, documents, records, and archives at appropriate places.
  • Coordinate with other departments and partners to achieve responsibilities within agreed timelines.
  • Assist the overall working of the Indian Pharmaceutical team.
  • Perform other tasks appointed by supervisors.
About the Company

FinOrion Pharma India Pvt. Ltd. is a wholly owned subsidiary of Orion Group, providing an opportunity to strengthen business relationships with current partners and support the headquarter in various office activities. The India office focuses on Global Operations and R&D activities.

Global Operations is one of the core areas of operations in Orion's India office, involved in procurement of in-licensed formulated products and pharmaceutical ingredients for in-house manufacturing in Finland. The Packaging Technology team creates and manages artworks for both in-licensed and in-house manufactured products. The Quality Assurance team audits partners globally for ensuring cGMP compliance.

CPD LCM India (Pharmaceuticals and Regulatory Affairs teams) supports product life cycle management, maintenance of marketing authorizations, and various other documentation requirements. 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, and more. With over 3000 professionals in different countries, Orion is the leading company in Finland as a manufacturer and marketer, as well as in R&D of pharmaceuticals.

What 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 a 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 (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
  • 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 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 are essential.

Please use the below Lifelancer link for job application and quicker response.

/jobs/view/d42fef3137bb60ca0bf3dcab05ff1504

Remote Work :

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