OverviewCandidate will have a strong technical understanding of tablet, capsule, and sachet formulations, and be able to contribute to end-to-end 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:
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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 scale-up.
Technology Transfer:
Participate in the transfer of developed formulations to the production team, ensuring smooth scale-up processes with proper documentation.
Collaborate with cross-functional teams to ensure successful technology transfer and commercialization of developed products.
experience
3show more OverviewCandidate will have a strong technical understanding of tablet, capsule, and sachet formulations, and be able to contribute to end-to-end 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 scale-up.
...
Technology Transfer:
Participate in the transfer of developed formulations to the production team, ensuring smooth scale-up processes with proper documentation.
Collaborate with cross-functional teams to ensure successful technology transfer and commercialization of developed products.
experience
3show more
