Job updates: Team Member - Process Development (oral Solids) - Ipdo, Hyderabad
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Role: Scientist Process Development Scientist (OSD) Reporting To: Process Expert Process Development (OSD) Work Location: IPDO, Hyderabad Click here to apply online Key Responsibilities: To work along with HPT for development of robust and scalable product. Participation in early stage of product development to build Processability. Carry out process DoE and derive suitable process parameter ranges. Carry out risk assessment to identify the impact of Critical process parameters and Critical material attributes on Critical quality attributes. Work out control strategies for mitigating identified risks in process. Application of scientific and engineering principles to develop process understanding and scale up product from laboratory to commercial scale (Scale up Correlation for all unit operations). Designing sampling plan for trial, Confirmatory and Submission batches. Execution of Trial, Confirmatory, Exhibit batches and monitoring stability data of the product. Preparation and Review of Confirmatory, Hold time, Stability and Submission batch Protocols/Reports. Participate / Investigate OOTs, OOSs, Incidents and Deviations and identify the root causes using investigational tools and propose the corrective action and preventive action plan Preparation, Review and Recommendations for Process Optimization Report. Deficiency response for all geography within the stipulated timeline. Knowledge of various regulatory guidelines and cGMP norms pertaining to Oral Solid Dosage forms. To provide support for conducting trials for evaluating New Technologies/ PAT Tools for better process understanding. Required Competencies: Good knowledge on Process development of Solid oral dosage form; Optimization and application of Scale-up rationale. Technical understanding/Sound knowledge on Equipments and Process. Knowledge on statistics for data analysis and data representation by statistical methods on submission batches. Good analytical and problem solving skills. Good inter personal skills and ability to collaborate with CFTs. Good communication skills, with high energy and ability to influence and persuade others. Focuse on continuous improvement, quality and safety aspects. Key Behavioral Attributes: Self-starter, able to work independently with minimal supervision. Excellent communication & Coordination skills and ability to work with a diverse cross-functional teams. Result oriented and willingness to work. Creative thinking ability Operating Network: Internal: FRD, ARD, PEF, PMO, RA, SCM, FTO, DQA, MSAT, Projects, Manufacturing, etc. External: NA Educational Qualification & Experience Required: M Pharmacy with 3-6 years experience in Process Development, Formulation development and Technology Transfer - OSD.