Job Opportunity: Executive / Sr. Executive – Formulation Development (Orals) at Sun Pharma

Pharmaceuticalcarrier; Vadodara; On-site; INR 6,00,000 - 9,00,000; Full time

Job summary

Une entreprise pharmaceutique de premier plan recherche un Executive / Sr. Executive en Développement de Formulations. Ce rôle inclut l'évaluation de la robustesse des produits et la gestion de documents techniques. Vous aurez l'occasion de travailler dans un environnement stimulant avec des collègues motivés avant de rejoindre une équipe de recherche et développement dynamique.

Qualifications

• Expérience de 2 à 5 ans dans le développement de formulations.
• Compétences en analyse statistique et conformité réglementaire.
• Maîtrise des outils tels que JMP et Minitab.

Responsibilities

• Évaluer et examiner les documents techniques pour les marchés régulés.
• Effectuer des évaluations statistiques pour l'extrapolation de durée de conservation.
• Préparer et réviser les procédures opérationnelles standard (SOP).

Skills

Document Management

Statistical Analysis

Regulatory Compliance

Education

M.Pharm

Tools

JMP

Minitab

TrackWise

Job description

About Sun Pharma

It is an Indian multinational pharmaceutical company headquartered inMumbai, India. It is one of the largest pharmaceutical companies in the world by market capitalization and revenue. Sun Pharma manufactures and markets a wide range of pharmaceutical formulations and active pharmaceutical ingredients (APIs) in various therapeutic areas including cardiology, psychiatry, neurology, gastroenterology, and oncology, among others. The company has a global presence with operations in over 150 countries and a strong focus on research and development to introduce innovative and affordable healthcare solutions.

Job Opportunity: Executive / Sr. Executive – Formulation Development (Orals)

Job Summary

As a member of the Product Robustness Review and Compliance Team, you will be responsible for assessing product robustness, reviewing technical documents for various markets, participating in harmonization activities, and ensuring compliance with regulatory standards. This role requires strong document management skills and a solid understanding of formulation development, statistics, statistical tools, and regulatory guidelines.

Areas of Responsibility

• Technical Document Review: Evaluate the adequacy, raw data, and quality of technical documents within defined service level agreements (SLAs) for regulated markets.
• Product Robustness Assessment: Conduct thorough assessments to ensure product robustness.
• Statistical Analysis: Perform and review statistical assessments using tools such as JMP and Minitab for probability assessments (S1/S2), shelf life extrapolation, inverse extrapolation, and Design of Experiments (DOE).
• SOPs and Guidelines: Prepare, revise, and review internal and harmonized Standard Operating Procedures (SOPs) and guidelines.
• Document Management:
  • Provide document numbering and maintain records as per SOP/guidelines.
  • Manage the issuance, archival, and retrieval of documents and laboratory notebooks (LNBs).
  • Oversee inventory management for LNBs.
  • Share historical data from the database with the team as needed.
• EDAMS Archival: Manage and provide inputs for Laserfiche scanning of documents for the Electronic Document and Archive Management System (EDAMS).
• Training: Conduct “Train the Trainer” activities.
• Quality Management System (QMS): Participate in QMS-related activities using the TrackWise system.
• EDMS Support: Provide support for the Electronic Document Management System (EDMS).

Additional Information

• Experience: 2 to 5 years
• Qualification: M.Pharm
• Location: Tandalja – R&D
• Industry Type: Pharma/Healthcare/Clinical Research
• Functional Area: Formulation Orals
• Application End Date: 20th June 2024

Join our team and contribute to the advancement of pharmaceutical formulations through rigorous assessment and compliance practices. Apply by 20th June 2024 to become part of a leading organization in the healthcare industry.

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