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Reviewer / Supervisor Method Validation

Navi Mumbai, MH
Job Code:
  • Biotechnology & Science
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Job Details

Should have knowledge on method development and trouble shooting of Analytical method. Should have minimum 4 to 5 years experience in reviewing the analytical reports. Should be aware of guidelines for validation of Analytical method such as ICH, RE 899 etc. Knowledge of finished product testing requirements. Should be well versed working on analytical instrument such as HPLC, Dissolution, GC, etc. Should have experience using chromeleon software for HPLC Operation. Should be able to independently review the method validation protocol. Review the method for any probable pitfalls before execution of methods. Independently investigate for any failure or OOE during the execution. Ensure strict adherence to set quality standards in the area of responsibility. Should keep himself abreast of any new requirement that may arise due to pharmacopeia. Maintain laboratory in a state of compliance with Novartis / Sandoz requirements & local regulations. Ensure Good Laboratory practices are followed in the laboratory. Ensure safe working conditions as per guidelines issued by HSE department. Should be able to effectively communicate within the team and outside the team. Monitor the laboratory for operational requirements. Develop, train and motivate people to ensure good work environment. Management of reference standard, samples etc.
Degree: M.Com. (Commerce) | M.Pharm. (Pharmacy) | M.Sc. (Science) | MA (Arts) | MBA/ PGDM | MCA/ PGDCA

Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 10-12


Product Development | Production Management | Production/Manufacturing/Maintenance
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