Senior Quality & Training Executive – Clinical Research
Location: Pune, India
Company: ProRelix Research
Employment Type: Full-Time
Experience Required: 3–5 Years
Preferred Joining: Immediate Joiners Preferred
Application Email: career@prorelixresearch.com
About the Company
ProRelix Research is a growing Clinical Research Organization (CRO) committed to delivering high-quality clinical trial management and regulatory-compliant research services. With a strong focus on operational excellence, regulatory integrity, and global quality standards, the organization supports sponsors in advancing safe and effective therapies.
Role Overview
The Senior Quality & Training Executive – Clinical Research will play a critical role in strengthening quality systems, regulatory compliance frameworks, and employee training initiatives across clinical operations. This position is ideal for professionals with hands-on experience in Quality Assurance (QA), audits, SOP lifecycle management, and inspection readiness within CROs, pharmaceutical companies, or clinical research environments.
The selected candidate will contribute to maintaining robust GxP-compliant systems and fostering a culture of continuous improvement in global clinical research practices.
Key Responsibilities
Conduct internal audits and support sponsor or regulatory inspections to ensure GCP compliance.
Develop, review, and manage Standard Operating Procedures (SOPs) aligned with global regulatory requirements.
Ensure audit readiness and compliance with ICH-GCP, regulatory authority guidelines, and sponsor standards.
Design and deliver structured employee training programs related to GCP, SOP updates, and regulatory processes.
Maintain quality documentation systems and training records.
Identify process gaps and implement corrective and preventive actions (CAPA).
Support quality metrics tracking and continuous improvement initiatives.
Collaborate with clinical operations, regulatory, and project management teams to strengthen quality oversight.
Required Experience
3–5 years of relevant experience in Quality Assurance and Training within:
Clinical Research Organizations (CROs)
Pharmaceutical companies
Clinical research environments
Demonstrated expertise in:
GCP audits
SOP development and management
Inspection readiness
Training coordination and delivery
Regulatory compliance oversight
Educational Qualifications
Bachelor’s or Master’s Degree in Life Sciences, Pharmacy, Clinical Research, Biotechnology, or a related field.
GCP Certification preferred.
QA certifications will be considered a strong advantage.
Core Competencies
Strong understanding of ICH-GCP guidelines and global regulatory frameworks
High attention to detail and documentation accuracy
Strong communication and training delivery skills
Ability to manage multiple quality initiatives simultaneously
Proactive approach toward compliance and continuous improvement
Why Join
This role offers the opportunity to contribute to global clinical research excellence while shaping quality systems that support regulatory success. Professionals seeking growth in Clinical QA, Regulatory Compliance, and GCP Audit Management will find strong career progression potential in this position.
How to Apply
Interested candidates may share their updated CV at:
career@prorelixresearch.com
Company Website: www.prorelixresearch.com
SEO Keywords:
Senior Quality Executive Jobs Pune, Clinical Research QA Jobs India, GCP Audit Careers, CRO Quality Assurance Jobs, SOP Management Roles Pharma, Clinical Training Executive Jobs, Inspection Readiness Careers, ProRelix Research Jobs Pune.
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