Quality Assurance Specialist

1 day ago

Ahmedabad, Gujarat, India beBeeQuality Full time ₹ 40,00,000 - ₹ 60,00,000

Daffodil Group is committed to ensuring compliance with regulatory guidelines, internal quality standards, and client requirements. Our mission is to maintain the highest quality assurance systems across all stages of research and laboratory operations, fostering a culture of excellence and integrity.

About the Role

As a Quality Assurance Executive, you will ensure compliance with regulatory guidelines, internal quality standards, and client requirements by monitoring, reviewing, and implementing Quality Assurance systems across all stages of research and laboratory operations.

Key Responsibilities:
  • Implement, maintain, and monitor Quality Management Systems (QMS) to guarantee compliance and efficiency.
  • Prepare, review, and control Standard Operating Procedures (SOPs), specifications, and master documents to standardize processes and minimize errors.
  • Conduct internal audits and support regulatory/third-party audits to identify areas for improvement and ensure compliance.
  • Manage deviations, change controls, out-of-specification (OOS), and out-of-trend (OOT) investigations to resolve issues promptly and efficiently.
  • Ensure proper documentation practices as per GLP/GMP requirements to maintain accuracy and transparency.
  • Review and approve analytical method validation and stability protocols/reports to ensure data reliability and consistency.
  • Ensure compliance with ICH, WHO, and other regulatory guidelines to stay up-to-date with industry standards and best practices.
  • Conduct training sessions for staff on quality systems, data integrity, and compliance to promote a culture of excellence and continuous learning.
  • Monitor equipment qualification, calibration, and preventive maintenance records to ensure optimal performance and minimize downtime.
  • Ensure data integrity and maintain audit readiness at all times to demonstrate commitment to quality and compliance.
Qualifications and Skills:
  • M.Pharm degree in Pharmaceutical Quality Assurance, Pharmaceutical Analysis, or relevant specialization.
  • 0–2 years (for fresher/entry-level) OR 2–5 years (for experienced candidates) of experience in QA/QC/Research Laboratory.
  • Prior exposure to GLP/GMP environment preferred but not required.
  • Strong knowledge of QA principles, regulatory guidelines (ICH, WHO, USFDA, EU-GMP).
  • Good understanding of pharmaceutical documentation and quality systems.
  • Analytical thinking, problem-solving, and attention to detail.
  • Proficiency in MS Office and laboratory documentation software.
  • Strong communication and teamwork skills.
Preferred Qualities:
  • Ethical, disciplined, and quality-oriented mindset.
  • Ability to handle audits and compliance requirements effectively.
  • Proactive approach to quality improvement and continuous learning.

We are committed to diversity and inclusivity in the workplace.

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