Quality Assurance Specialist

4 days ago

Madurai, Tamil Nadu, India beBeeSterileInjectables Full time ₹ 15,00,000 - ₹ 20,00,000

Job Summary:

We are seeking a highly experienced Validation Specialist to join our team.

The ideal candidate will have a strong background in sterile injectable manufacturing processes, aseptic techniques, and validation methodologies.

The role will involve preparing, reviewing, and approving validation protocols and reports for media fill studies, installation qualification, operational qualification, and performance qualification.

The successful candidate will also be responsible for analyzing remote media fill results, identifying deficiencies, and recommending corrective or preventive actions.

Key Responsibilities:

  • 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
  • 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

Education and Qualifications:

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

Requirements:

  • A minimum of 10-15 years of experience in sterile injectable manufacturing processes
  • Proven track record of successfully leading cross-functional teams
  • Demonstrated expertise in validation methodologies and regulatory guidelines
  • Excellent analytical and problem-solving skills
  • Strong communication and documentation skills

Preferred Qualifications:

  • Experience with QMS tools and software

Working Conditions:

  • Work is performed in a standard office environment

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