Validation Expert

1 day ago

Chennai, Tamil Nadu, India beBeeQuality Full time ₹ 15,00,000 - ₹ 20,00,000
Job Title: Quality Assurance Specialist

We are seeking a highly experienced and skilled Quality Assurance Specialist to join our team. The successful candidate will have expertise in sterile injectable manufacturing processes, aseptic techniques, and validation methodologies.

  • Key Responsibilities:
  • Aseptic process integrity is ensured by preparing, reviewing, and approving validation protocols and reports for media fill studies.
  • Analyzing remote media fill results, identifying deficiencies, and recommending corrective or preventive actions.
  • Candidate prepares and reviews area qualification protocols and reports for classified manufacturing areas (Grade A–D) based on environmental monitoring and qualification data from the site.
  • Preparing and reviewing periodic requalification protocols, data, and environmental monitoring summaries for compliance with cGMP and regulatory requirements.
  • Preparing, reviewing, and approving Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for manufacturing equipment.
  • Supporting and participating in Factory Acceptance Test (FAT) execution for equipment at vendor locations.
  • Preparing and reviewing utility qualification documentation, including HVAC, Water for Injection (WFI), and compressed air system validation.
  • Preparing, reviewing, and approving cleaning validation protocols and reports to ensure adequacy, compliance, and suitability for product changeover.
  • Preparing, reviewing, and approving process validation protocols, data, and reports to confirm process robustness and consistency in product quality.
  • Key Skills and Competencies:
  • Expertise in sterile injectable manufacturing processes and aseptic techniques.
  • 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.

Benefits of this role include:

  • Opportunity to work in a dynamic environment
  • Chance to develop new skills and expertise
  • Collaborative team environment
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