Senior Quality Assurance Specialist

2 days ago

Ahmedabad, Gujarat, India beBeeQuality Full time ₹ 80,00,000 - ₹ 1,20,00,000

Job Title: Quality Assurance Specialist

The role of the QA Specialist is to ensure that all quality-related processes and procedures are in place and followed across the organization.

  • Develop, implement, and maintain Quality Management Systems (QMS).
  • Prepare, review, and control Standard Operating Procedures (SOPs), specifications, and master documents.
  • Conduct internal audits and support regulatory/third-party audits.
  • Manage deviations, change controls, out-of-specification (OOS), and out-of-trend (OOT) investigations.
  • Evaluate and improve data integrity practices as per GLP/GMP requirements.
  • Review and approve analytical method validation and stability protocols/reports.
  • Ensure compliance with ICH, WHO, and other relevant regulatory guidelines.
  • Deliver training sessions for staff on quality systems, data integrity, and compliance.
  • Monitor equipment qualification, calibration, and preventive maintenance records.
  • Guarantee data integrity and maintain audit readiness at all times.

Requirements

  • Bachelor's or Master's degree in a relevant field such as Pharmacy, Quality Assurance, or a related specialization.
  • 1-3 years' experience in QA/QC/Research Laboratory environment.
  • Prior exposure to GLP/GMP environment preferred.

Skills

  • Strong understanding of QA principles, regulatory guidelines, and quality management systems.
  • Excellent analytical thinking, problem-solving, and attention to detail.
  • Proficiency in MS Office and laboratory documentation software.
  • Strong communication and teamwork skills.

Preferred Skills

  • Ability to handle audits and compliance requirements.
  • Proactive approach to quality improvement and continuous learning.

Benefits

This role offers a unique opportunity to contribute to a dynamic organization that prioritizes quality and excellence.

Additional Information

For this position, we seek an individual who can effectively communicate and collaborate with colleagues across the organization.

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