Senior Quality Assurance Specialist

5 days ago

Ahmedabad, Gujarat, India beBeeQualityAssurance Full time ₹ 6,00,000 - ₹ 12,00,000

The Quality Assurance role is a critical component of our organization's success.

About the Position

As a Quality Assurance professional, you will be responsible for ensuring compliance with regulatory guidelines and internal quality standards. This involves monitoring, reviewing, and implementing Quality Assurance systems across all stages of research and laboratory operations.

Responsibilities:
  • Develop, maintain, and monitor Quality Management Systems (QMS).
  • Create, 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 documentation practices to ensure adherence to GLP/GMP requirements.
  • Review and approve analytical method validation and stability protocols/reports.
  • Ensure compliance with ICH, WHO, and other regulatory guidelines.
  • Deliver training sessions on quality systems, data integrity, and compliance.
  • Monitor equipment qualification, calibration, and preventive maintenance records.
  • Maintain data integrity and ensure audit readiness at all times.
Qualifications and Requirements
  • M.Pharm (Pharmaceutical Quality Assurance / Pharmaceutical Analysis / Relevant Specialization).
  • Experience: 0–2 years (for fresher/entry-level) OR 2–5 years (for experienced candidates) in QA/QC/Research Laboratory.
  • Prior experience in a GLP/GMP environment is preferred.
Essential Skills and Qualities
  • Demonstrated understanding of QA principles and regulatory guidelines.
  • Knowledge of pharmaceutical documentation and quality systems.
  • Analytical thinking, problem-solving, and attention to detail.
  • Proficiency in MS Office and laboratory documentation software.
  • Effective communication and teamwork skills.
Desirable Skills and Attributes
  • A commitment to ethical behavior and a disciplined approach to quality assurance.
  • Ability to handle audits and compliance requirements.
  • A proactive approach to quality improvement and continuous learning.

We value diversity and inclusivity in the workplace.

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