-Good understanding of QbD requirements for development formulation which shall include QTPP, CQA, DOE, etc.
-Hands on experience of developing a Lyophilized dosage forms with intensive knowledge of Freeze drying process.
-Review & ensure completeness of QbR based dossier for filing with help of regulatory teams along with other technical documents writing.
-Complete understanding of USFDA, EMA, MHRA, and ICH guidelines, and the regulatory requirements of various International Regulatory Agencies.
-DOE based process optimization & successful technology transfer at the manufacturing site for demonstration of registration batch manufacturing.
-Specification setting, Polymorphism, Interpretation of Characterization data, ICH Stability Studies, compliance to 21 CFR Part 11, review support to regulatory submissions, and support to Intellectual Property Group etc.
-Novel drug delivery systems: (NDDS)
Oral Drug Delivery Systems.
Parenteral and Implant Drug Delivery Systems
Pulmonary and Nasal Drug Delivery
Trans mucosal Drug Delivery
-Ability to circumvent PSD, Polymorph or % Excipient patent claims of innovator or other generic competitors.
-Ability to do IV/IV correlation.
-Ensure single point of contact for products within the site and across sites for multi-site products, as far as process technical issues are concerned.
-To coordinate with R&D and other departments at plant in completing activities related to exhibit batches
-To take part in responding process related received from regulatory agency to ensure to complete projects with minimum possible API and excipients in order to reduce the project cost.
-To drive the process R&D team to meet desired timelines with respect to project completion in absence of Head PDL Monitoring and technical guidance of scientist for trial Exhibit batch Validation batches to ensure the timelines.
-To support the R&D to define the process Exposure to Quality by design concepts.
Salary: INR 4,00,000 - 7,00,000 P.A.
Industry:Pharma / Biotech / Clinical Research
Functional Area:Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role:Analytical Chemistry Associate/Scientist
Desired Candidate Profile
UG:B.Pharma - Pharmacy
PG:M.Pharma - Pharmacy
Unichem Laboratories Ltd
With formulations constituting the core of the companyÃ¢â‚¬â„¢s business, Unichem is backward integrated to API Manufacturing, which adds value to the customer in terms of quality and sustainability.
Contact Company:Unichem Laboratories Ltd