Clinical Quality Assurance Compliance Specialist

1 day ago

Aurangabad, Maharashtra, India beBeeQuality Full time ₹ 20,00,000 - ₹ 25,00,000
Job Title: Clinical Quality Assurance Compliance

We are seeking a highly experienced professional to join our team as a Clinical Quality Assurance Compliance Specialist.

The successful candidate will have a strong background in quality assurance and compliance, with a proven track record of ensuring the integrity of clinical trials.

About This Role:

This role is responsible for overseeing all aspects of clinical trial activities from a quality perspective. The ideal candidate will have experience working in a matrix business environment and be familiar with recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations, and other applicable regulations pertaining to clinical trials.

The successful candidate will be responsible for establishing procedures and training programs that ensure protection of human subjects from research risk, reliability/integrity of data, and internal consistency and quality compliance measures.

  • Develop and implement a risk-based and flexible approach to quality compliance within the function.
  • Identify and decide team member's job-specific SOP training requirements.
  • Preparation of SOPs related to QC function and support in review of SOPs specific to Medical Science, Clinical Team, and Data Management Team.
Requirements and Qualifications:

To be successful in this role, you will need to have:

  • 5 years' experience in a CRO/Pharma/Biotech organization in Quality Department with experience of Quality Activities in Clinical Research Department.
  • Strong eye for detail and ability to spot inconsistencies.
  • Good conflict management skills.
  • Must have experience in handling audits & inspections of DCGI, US FDA.
Benefits:

This role offers a competitive salary and benefits package, including:

  • A comprehensive health insurance plan.
  • A retirement savings plan.
  • Ongoing training and development opportunities.
What We Offer:

We offer a dynamic and supportive work environment, with opportunities for career growth and development. Our team is passionate about delivering high-quality results, and we are committed to excellence in everything we do.

We are an equal opportunities employer and welcome applications from all qualified candidates.

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