Overview
Candidate will have a strong technical understanding of tablet capsule and sachet formulations and be able to contribute to endtoend product development processes. The role will involve working in a regulated environment including compliance with cGMP and ICH guidelines. The candidate should also have excellent documentation skills and experience in the development of benchmark products.
Key Responsibilities:
Product Development:
Develop tablet capsule and powder dosage forms in compliance with regulatory requirements (ROW) and company standards.
Formulate and develop products as per the agreed specifications ensuring product stability efficacy and safety.
Ensure the accurate and timely completion of all product development documentation including batch records and development reports (MFR/Product Development Report).
Regulatory Compliance:
Prepare registration samples for tablet dosage forms as per the regulatory requirements ensuring that all development work aligns with the respective regional (ROW) guidelines and standards.
Ensure all activities comply with cGMP/ICH guidelines during formulation development and production scaleup.
Technology Transfer:
Participate in the transfer of developed formulations to the production team ensuring smooth scaleup processes with proper documentation.
Collaborate with crossfunctional teams to ensure successful technology transfer and commercialization of developed products.