About this role
- Enhancing, devising, and implementing technically stable and successful formulations of finished products to meet the company requirements for ANDA (US), EU, Market for semi-solid dosage form
- Improvising formulations, Formulation optimization, Process optimization using QbD approach (US market).
- Efficiently worked at various Third-party locations for manufacturing for newly developed product as well as location transfer of existing products. Coordinating activities, preparation of technical documents, material arrangement (procurement or transfer), manufacturing, analysis, launch of product.
- Taking stringent measures including preparation of necessary technical documents to ensure compliance with quality standards and customer requirements. Generating, reviewing and approving technical documents like MFR, MPR, BMR, BPR, Trade dress, Product Development Report (PDR), Stability study protocol, Hold time study protocol, in- use study protocol, Alcohol dose dumping study protocol, Bill of Material (BOM) and relevant SOPs; implementing filing systems in relation to materials used for development of product.
- Performing patent search, evaluation, and literature review on formulation projects, conducting, and interpreting the stability studies as per the ICH guidelines.
Qualifications
Education: B.pharm, M.Pharm or equivalent
Experience: 5-8 Years in Formulation Documentation (R&D) with USFDA, EU, MHRA, ANVISA requirement
Technical Skills: Expertise in preparing and reviewing regulatory documents and reports, Strong understanding of data management and documentation tools, Proficiency in formulation design and development
Soft Skills: Excellent written and verbal communication skills, Problem-solving mindset and proactive approach to challenges, Ability to work independently and as part of a team, Strong attention to detail and organizational skills