Clinical Quality Assurance Compliance Specialist

2 days ago

Nashik, Maharashtra, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 20,00,000
Clinical Quality Assurance Compliance Specialist

Job Overview:

We are seeking an experienced Clinical Quality Assurance Compliance Specialist to oversee end-to-end clinical trial activities from a quality perspective. The ideal candidate will be accountable for ensuring compliance with regulatory requirements and guidelines.

Main Responsibilities:

  • Oversight of all study-related activities, processes, and procedures to ensure adherence to regulations and guidelines.
  • Review and development of Standard Operating Procedures (SOPs) related to Quality Compliance within the function.
  • Quality review of clinical trial medical science activities, including synopsis, protocol, clinical study reports, and SOPs in line with ICH GCP requirements.
  • Quality review of clinical trial operations activities, including site feasibility, site selection visit, site initiation, and close-out activities in line with ICH GCP requirements.

Required Skills and Qualifications:

  • Strong eye for detail and ability to identify inconsistencies.
  • Effective conflict management skills.
  • Proven experience in handling audits and inspections, particularly with DCGI and US FDA.
  • Thorough knowledge of recent GCP guidelines, ICMR guidelines, and applicable regulations pertaining to clinical trials.
  • Experience working in matrix business environments is a plus.
  • Strong track record of success demonstrated through annual performance ratings and/or professional accomplishments.

Benefits:

This role offers a unique opportunity to develop and implement a risk-based approach to Quality Compliance within the organization.

Others:

The successful candidate will have the opportunity to work with cross-functional teams and contribute to the growth and success of the organization.

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