Sterile Injectable Manufacturing Specialist

2 days ago

Gulbarga, Karnataka, India beBeeQualityAssurance Full time ₹ 2,00,00,000 - ₹ 2,50,00,000
Job Title:

A highly skilled Quality Assurance Specialist is required for this key role.

Key Responsibilities:
  • Validate protocols and reports for media fill studies, ensuring aseptic process integrity.
  • Analyze remote media fill results, identify deficiencies, and recommend corrective or preventive actions.
  • Prepare area qualification protocols and reports for classified manufacturing areas (Grade A–D) based on environmental monitoring and qualification data.
  • Prepare periodic requalification protocols, data, and environmental monitoring summaries for compliance with cGMP and regulatory requirements.
  • Approve Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for manufacturing equipment.
  • Support Factory Acceptance Test (FAT) execution for equipment at vendor locations.
  • Prepare utility qualification documentation, including HVAC, Water for Injection (WFI), and compressed air system validation.
  • Approve cleaning validation protocols and reports to ensure adequacy, compliance, and suitability for product changeover.
  • Approve process validation protocols, data, and reports to confirm process robustness and consistency in product quality.
  • Maintain and update the Validation Master Plan (VMP), ensuring alignment with regulatory expectations.
Required Skills and Competencies:
  • Deep knowledge of sterile injectable manufacturing processes and aseptic techniques.
  • Expertise in validation methodologies and regulatory guidelines.
  • 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.

Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field is required. 10-15 years of experience in the pharmaceutical industry is necessary.

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