Validation Expert

2 days ago


Hyderabad, Telangana, India beBeeValidation Full time ₹ 1,00,00,000 - ₹ 1,50,00,000
Job Title: Validation Expert

This position involves the preparation of validation documentation, change evaluations, and execution of tasks to meet regulatory requirements. Your role is to ensure that site validation programs align with global expectations.


Key Responsibilities:
  • Preparation of process and cleaning validation documentation as well as change evaluations
  • Executing change tasks to meet cGMP requirements on time and with quality
  • SUPPORTING PROCESS VALIDATION LIFECYCLE ACTIVITIES
  • CREATING LOCAL TEMPLATES FOR THE RESPECTIVE VALIDATION DOCUMENTATION
  • PARTICIPATING IN PRE-VALIDATION ACTIVITIES AND RISK ASSESSMENTS
  • PROVIDING TECHNICAL EXPERTISE AND FACILITATING THE CREATION OF A QUALITY RISK ASSESSMENT

Required Skills and Qualifications:
  • Bachelor's degree in a relevant field, such as pharmacy or chemical engineering
  • Minimum 5 years of experience in MS&T (Process and Cleaning and Transport Validations) or in the manufacturing of pharmaceutical drug substance in a sterile/large molecules platform/facility
  • Familiarity with regulatory guidance on validation, product filing, and post-approval changes
  • Proven project management experience in a cross-functional environment
  • Expertise in reviewing and writing technical reports

About this Role:

This role offers the opportunity to work on high-profile projects and contribute to the development of site validation programs. If you have a passion for process validation and a desire to work in a dynamic environment, we encourage you to apply.


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