JOB DESCRIPTION/RESPONSIBILITIES:

• Develop robust formulations and processes for various dosage forms as required by the company.
• Plan and contribute to project-related technical activities.
• Review and approve technical documents including Product Development Report, and other relevant documents for regulatory filing purpose.
• Interaction with procurement team, API and excipients manufacturers, Machine manufacturers, CROs and CMOs as needed.
• Work proactively with other cross-functional groups to execute product/ process improvement and optimization, Product Lifecycle management, change controls associated with Manufacturing and Packaging master records, SOPs and protocols.
• Create and review SOPs, as well as review appropriate system documentation and test results for accuracy and completeness and compliance with SOPs/GMP requirement.
• Provide relevant documents to Regulatory Affairs in a timely manner for registration filings and Supplements filing.
• Review of batch records, process characterization reports, Annual Product Quality Review Report, validation reports and investigation reports where necessary.
• Participate in designing and approval of tablet punches and blister change parts.
• Review Formulation Development Protocol, Processes and Report to ensure the Development of robust formulations and processes.
• Plan and contribute to project-related technical activities by reviewing the activities where required.
• Review of technical document and communications shared by procurement team, API and excipients manufacturers, Machine manufacturers, CROs and CMOs as needed.
• Review of SOPs, appropriate system documentation and test results for accuracy and completeness and compliance with SOPs/GMP requirement.
• Preparation and review of Product Dossier.
• Review of batch records, process characterization reports, Annual Product Quality Review Report, validation reports and investigation reports where necessary.
• Ensure Pharmaceutical Development Protocol preparation, execution and reporting.
• Ensure document preparation i.e., SOPs, Protocols, Master Formula Records.
• Review and/ or Approval of prepared document.
• Review and/ or Approval of technical drawing (tools and change part), where needed.
• Any additional task assigned by Management.

SKILLS REQUIRED:

• Minimum of 5-8years of relevant experience in Pharmaceutical Development
• Knowledge of Quality by Design (QbD) principles towards dosage form development, planning of trials by DOE for development and execution of trial batches.
• Knowledge of current Good Manufacturing Practices.
• Member of relevant professional body.

QUALIFICATION:

• Minimum of B.Sc., HND or equivalent in Chemistry, Biochemistry, Biological Sciences