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Senior Validation Expert

3 weeks ago

Hyderabad Secunderabad Telangana, India beBeeValidation Full time
Job Description

We are seeking a highly skilled and experienced Validation Specialist to join our team. In this role, you will be responsible for ensuring the quality and integrity of our products by developing and implementing effective validation strategies.

Your primary focus will be on process and cleaning validation, as well as providing technical expertise to support the development of new products. You will work closely with cross-functional teams to ensure that all validation activities are completed in a timely and efficient manner.

  • Key Responsibilities:
  • Develop and implement process and cleaning validation strategies to ensure compliance with regulatory requirements.
  • Provide technical expertise to support the development of new products, including evaluation of physico-chemical buffer stability and corrosive agents.
  • Prepare and review validation documentation, including risk assessments and deviation reports.
  • Collaborate with cross-functional teams to ensure successful project execution.
Required Skills and Qualifications
  • Bachelor's Degree: Pharmacy, Pharmaceutical Technology, Chemical Engineering, Biotechnology, Chemistry, or equivalent science streams.
  • Minimum 5 Years of Experience: MS&T (Process and Cleaning and Transport Validations) or manufacturing of pharmaceutical Drug substance in Sterile/Large Molecules platform/facility.
  • Regulatory Knowledge: Familiarity with regulatory guidance on validation, product filing, and post-approval changes.
  • Project Management: Proven experience in a cross-functional environment.
  • Communication Skills: Excellent written and verbal communication skills.
Benefits
  • Opportunity to Work with Experienced Professionals: Collaborate with a team of experts in the field of validation and quality assurance.
  • Professional Development: Opportunities for growth and professional development in a dynamic and challenging environment.
  • Competitive Salary and Benefits: A comprehensive compensation package that includes a competitive salary, benefits, and perks.
Others
  • Language Skills: Proficiency in English (oral and written), and knowledge of German is an advantage.