Dr. Reddy’s Laboratories Ltd. is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets across the globe.
Job Title : Lead LCM
Job Description:
Purpose
To be a part of LCM-PQ (Life Cycle Management – Product Quality) – To execute projects related to Life Cycle Management –Product Quality for a set of given products at different units(FTOs & CTOs). Incumbent should be able to understand inter-relationship between Critical Quality Attributes, Critical Material Attributes and Critical Process Parameters and their impact on manufacturing process. Incumbent will train MSAT-teams at each site on statistical concepts required for implementing LCM-PQ related projects.
Key Responsibilities
- Driving long term robustness projects at site(FTOs & CTOs).
- Data analysis for evaluating the potential area for ensuring product robustness. Able to make observations, inference and recommendations based on data analysis.
- Support site teams involved in investigation by applying statistical tools like Control Charts, Capability Analysis, DoEs, ANOVA, Regression, multivariate analysis etc. for the data as applicable.
- Should understand trends of data in APQR (Annual Product Quality Review) and CPV (Continuous Process Verification) and support site MSAT teams for the same.
- Hands on Experience with SAP and statistical software like Minitab, SIMCA or equivalent.
- Train the site teams with statistical concepts required for ensuring process robustness & investigation.
- Basic understanding of QbD concepts and other Regulatory guidelines (for example process Validations)
Educational Qualification & Experience
BE/ BTech in Chemical Engineering or MSc(Chemistry) with 3 to 6 Years of experience in Pharmaceutical Industry. At least 2 years worked in using Lean Six sigma tools and methodology. Green Belt / Black Belt certification in Lean Six Sigma is desired.
