Senior Validation Specialist

4 days ago


Mangalore, Karnataka, India Lifelancer Full time
Job Title: Senior Validation Specialist

We are seeking a highly skilled Senior Validation Specialist to join our team at Lifelancer.

About the Role:

  • The ideal candidate will have extensive experience in pharmaceutical validation systems, with a focus on facilities, utilities, equipment, and computerized systems.
  • They will be responsible for ensuring compliance with regulatory requirements and guidelines, such as ICH Q2, ICH Q7, WHO, US FDA, EU guidelines, 21 CFR, ISPE, PDA, and PICS.
  • The successful candidate will also possess strong analytical skills, excellent communication abilities, and the ability to work effectively in a dynamic environment.

Requirements:

  • Minimum 3 years of experience in pharmaceutical validation systems (facilities, utilities, equipment, and computerized systems)
  • Manufacturing Computerized System Validation (CSV) deliverable preparation/review experience
  • QMS procedures knowledge
  • Knowledge of validation guidelines per different regulatory requirements and industrial bodies
  • Interpersonal skills to establish collaboration with cross-functional teams

Preferred Qualifications:

  • Bachelor's or Master's degree in a relevant field
  • Technical knowledge in chemical API is a must; biologics and injectables are an added value

About Syngene:

Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. We connect talented individuals with opportunities in pharma, biotech, health sciences, healthtech, and IT domains.

Salary: The estimated salary for this role is ₹1,200,000 - ₹1,800,000 per annum, depending on location and experience.

Why Choose Us:

  • We offer a competitive salary package, including benefits and opportunities for growth
  • A dynamic and collaborative work environment
  • Access to cutting-edge technology and resources


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