Assurance Compliance Professional

2 days ago

Surat, Gujarat, India beBeeRegulatory Full time ₹ 6,00,000 - ₹ 15,00,000
Quality Assurance Specialist

Job Description:

The Quality Assurance Specialist will oversee the implementation and maintenance of quality management systems across all stages of research and laboratory operations. This involves monitoring, reviewing, and ensuring compliance with regulatory guidelines, internal quality standards, and client requirements.

Responsibilities:

  • Implement, maintain, and monitor 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.
  • Ensure proper documentation practices as per GLP/GMP requirements.
  • Review and approve analytical method validation and stability protocols/reports.
  • Ensure compliance with ICH, WHO, and other regulatory guidelines.
  • Conduct training sessions for staff on quality systems, data integrity, and compliance.
  • Monitor equipment qualification, calibration, and preventive maintenance records.
  • Ensure data integrity and maintain audit readiness at all times.

Qualifications and Skills:

Strong knowledge of QA principles and regulatory guidelines is essential. A Master's degree in Pharmaceutical Quality Assurance or a related field is preferred, along with excellent analytical and problem-solving skills.

Benefits:

This role offers a unique opportunity to work in a dynamic environment with a focus on quality and compliance. The ideal candidate will be able to work effectively in a team and have strong communication and interpersonal skills.

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