QA-Validation

3 weeks ago

Kollam, Kerala, India Medivant Healthcare Full time

Salary Between 15-20 Lacs

QA-Validation – Sterile Injectables (Candidate with B1/B2 USA Visa Preferred)

Experience Required: 10-15 years

Location: Remote

Department: Quality Assurance

No. of vacancy: 01

Key Responsibility:

Validation Activities:

  • Prepare, review, and approve validation 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 and review area qualification protocols and reports for classified manufacturing areas (Grade A–D) based on environmental monitoring and qualification data from the site.
  • Prepare and review periodic requalification protocols, data, and environmental monitoring summaries for compliance with cGMP and regulatory requirements.
  • Prepare, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for manufacturing equipment.
  • Support and participate in Factory Acceptance Test (FAT) execution for equipment at vendor locations (onsite when required, otherwise through live remote connection), ensuring test protocols are followed and results are documented.
  • Prepare and review utility qualification documentation, including HVAC, Water for Injection (WFI), and compressed air system validation.
  • Prepare, review, and approve cleaning validation protocols and reports to ensure adequacy, compliance, and suitability for product changeover.
  • Prepare, review, and 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 and site needs

Key Skills and Competencies:

  • In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques.
  • 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.

Education and Qualifications:

  • Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.

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