Strategic Quality Assurance Specialist

2 weeks ago

Nellore, Andhra Pradesh, India beBeeCompliance Full time ₹ 30,00,000 - ₹ 50,00,000

Ensuring the Integrity of Clinical Trials: A Strategic Role

 

  • This role is accountable for overseeing end-to-end clinical trial activities from a quality perspective, ensuring compliance with regulations and guidelines to guarantee 24x7 inspection/audit readiness.

 

Key Responsibilities:

  • Develop risk-based quality compliance measures to safeguard participants, data, and internal consistency.
  • Establish procedures and trainings to ensure protection of human subjects and reliability/integrity of data.
  • Identify and assign team member's job-specific SOP training requirements and maintain oversight of training.
  • Prepare SOPs related to QC function and support in reviewing SOPs specific to Medical science, Clinical team, and Data Management team.

 

Requirements:

  • A minimum of 5 years' experience in a CRO/Pharma/Biotech organization in the Quality department with experience of quality activities in Clinical Research department.
  • Strong attention to detail and ability to spot inconsistencies, good conflict management skills, and experience in handling audits & inspections.
  • Thorough knowledge of recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations, and other applicable regulations pertaining to clinical trials.

 

What We Offer:

  • Opportunities to develop strategic quality initiatives that drive excellence in clinical trials.
  • Collaborative work environment with cross-functional teams.
  • Professional growth and development opportunities.

 

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