Hyderabad

Title Manager
Services Inogent CMS
Job Function Inogent CMS
Job Grade Manager
SBU/ Division Inogent CMS
Candidate Profile Qualification
Experience
Location Hyderabad
Job Responsibilities
  • Making available detailed written procedures that could affect the quality of the finished product.
  • Ensure adherences to GMP/GLP/GDP guidelines and SOPs across the organization.
  • Release or reject of APIs/Intermediates
  • Review and submission of USDMF/CTD/COS
  • Ensuring SOPs are available for all quality related activities and are current.
  • Ensure all deviations are addressed before release of all products.
  • Review of site master file and ensure that it is available in the plant with full details.
  • Handling of new product developments.
  • Ensuring the fulfillment of training activities as per SOP.
  • Handling of Audits, maintain records, data integrity and safety.
Competencies
  • Knowledge and compliance with regulatory guidelines.
  • Knowledge of quality management systems and data investigative techniques.
  • Knowledge of adherence to GXP guidelines.
  • Data integrity, safety and continual improvement.
  • Knowledge of analytical method validation and custom synthesis requirements.