hireejobs
Register for Job
Hyderabad Jobs
Banglore Jobs
Chennai Jobs
Delhi Jobs
Ahmedabad Jobs
Mumbai Jobs
Pune Jobs
Vijayawada Jobs
Gurgaon Jobs
Noida Jobs
Oil & Gas Jobs
Banking Jobs
Construction Jobs
Top Management Jobs
IT - Software Jobs
Medical Healthcare Jobs
Purchase / Logistics Jobs
Sales
Ajax Jobs
Designing Jobs
ASP .NET Jobs
Java Jobs
MySQL Jobs
Sap hr Jobs
Software Testing Jobs
Html Jobs
IT Jobs
Logistics Jobs
Customer Service Jobs
Airport Jobs
Banking Jobs
Driver Jobs
Part Time Jobs
Civil Engineering Jobs
Accountant Jobs
Safety Officer Jobs
Nursing Jobs
Civil Engineering Jobs
Hospitality Jobs
Part Time Jobs
Security Jobs
Finance Jobs
Marketing Jobs
Shipping Jobs
Real Estate Jobs
Telecom Jobs

OSD AR&D Expert

7.00 to 10.00 Years   Hyderabad   19 May, 2020
Dr Reddys Laboratories Ltd
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaOperations Management / Process Analysis
EmploymentTypeFull-time

Job Description

Role :AR&D ExpertRole Band :BlueNo. of Positions : 1Work Location : IPDO, BachupallyKey Responsibilities:

  1. Method Development & Validation
Design strategy to meet the challenge for complex products and assess method robustness in the light of QbD to strengthen method design- Interpret data and troubleshoot anticipated problems in the course of development and validation within area of specialization through relevant mitigation plans/alternative strategies-Guide the teams to prepare technical justification reports for changes in method/process/formula Seek alignment across cross-functional stakeholders with business goals in the course of product development;Proactively identify and understand the regulatory requirements in relation to product characterization/ development requirements
  1. Product Characterization
Identify and execute the characterization startegies for complex generics, collaborate with external experts to develop methods where facility is not available in house. Design regulatory strategy for characterization along with R&D and regulatory teams to show pharmaceutical equivalence for faster approval. Identify and interpret data trends in sample analysis
  1. Regulatory Support
Review complex queries from regulatory authorities/customers related to formulations Guide associated teams in responding to complex deficiencies related to area of specialization Anticipate potential queries from regulatory authorities/customers aforehand and propose relevant measures to address the same
  1. New Technologies
Evaluate new technologies for application in projects to meet the new regulatory challenges/ requirements.Develop proof of concept for new complex technologies with support of group of experts- Build external collaboration to bring best practices and new technologies to the organization. Evaluate new technologies for simplification of existing methods for faster analysis & results.
  1. Coaching & Mentoring
Coach, and provide technical guidance to, Analytical R&D team members on complex execution issues related to area of expertisePeriodically impart training on critical / complex technical areas to enhance team s skills and performance- Implement technical skill development plans for teams under purview to enhance their knowledge and capabilitiesEducation & Experience: M Pharm / M.Sc 10-15 years of experience in having designed Analytical Strategy for product development; having guided analytical method development / validations / transfers for at least 6-8 projects and at least one complex product (such as complex sugars, polymers, peptides & proteins), with an exposure to DoE & QbD and data analysis; having identified external labs / universities / research institutes for new technologies evaluation.,

Keyskills :
proofofconcept analyticalmethoddevelopment environmentalimpactassessment dataanalysis skilldevelopment methoddevelopment productdevelopment regulatoryrequirements nalyticalrd

APPLY NOW

OSD AR&D Expert Related Jobs

© 2019 Hireejobs All Rights Reserved