Senior Validation Specialist

5 days ago

Varanasi, Uttar Pradesh, India beBeeValidation Full time ₹ 15,00,000 - ₹ 20,00,000

Job Title: Senior Validation Specialist

About the Role:
  • The ideal candidate will have expertise in regulatory guidelines, strong analytical skills, and excellent communication abilities.

This challenging role requires experience in quality assurance and validation of sterile injectables. Key responsibilities include preparing, reviewing, and approving validation protocols and reports for media fill studies.

The successful candidate will also analyze remote media fill results, identify deficiencies, and recommend corrective or preventive actions. Additionally, they will prepare and review area qualification protocols and reports for classified manufacturing areas based on environmental monitoring and qualification data from the site.

The specialist will also prepare and review periodic requalification protocols, data, and environmental monitoring summaries for compliance with cGMP and regulatory requirements. Furthermore, they will prepare, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for manufacturing equipment.

Key Skills and Competencies:
A bachelor's degree in pharmacy, biotechnology, microbiology, or a related field is required. The ideal candidate will have in-depth knowledge of sterile injectable manufacturing processes and aseptic techniques.

Requirements:
  • Expertise in validation methodologies and regulatory guidelines (US FDA, cGMP etc.)
  • Strong analytical and problem-solving skills
  • Effective communication and documentation skills
  • Ability to manage cross-functional teams and prioritize tasks
  • Proficiency in QMS tools and software

Benefits include working with experienced professionals and having opportunities to grow and develop within the organization. If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.

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