Job Opportunity: Quality Assurance (QA) Professional at Clinvigilant

Job Summary

Clinvigilant is seeking a detail-oriented and experienced Quality Assurance (QA) Professional to join our growing team in Ahmedabad. This role is ideal for a dedicated professional with over three years of experience in clinical research quality systems, regulatory compliance, and SOP management. As a member of our QA department, you will play a critical role in maintaining the highest standards of data integrity and regulatory adherence, ensuring that all clinical processes align with global expectations. This is an excellent opportunity for a candidate looking to advance their career within a fast-paced, high-impact clinical research environment.

Key Responsibilities

The successful candidate will be responsible for overseeing and upholding the quality of our clinical research operations. Primary duties include:

• Compliance Oversight: Ensure all clinical research activities strictly adhere to ICH-GCP guidelines, regulatory requirements, and internal Standard Operating Procedures (SOPs).
• Documentation Management: Manage and maintain accurate QA documentation, records, and databases. Perform regular reviews and approvals of SOPs to ensure they remain current and compliant.
• Audit Management: Conduct internal audits to evaluate operational effectiveness and regulatory readiness. Prepare comprehensive audit reports and communicate findings to the relevant stakeholders.
• Process Improvement: Identify quality gaps, mitigate risks, and implement robust Corrective and Preventive Actions (CAPA) to prevent recurrence of non-compliance.
• Inspection Readiness: Proactively maintain a state of inspection readiness for all projects, ensuring total compliance with data integrity standards.
• Collaboration: Provide ongoing support for clinical research quality processes across various departments to foster a culture of quality and accountability.

Requirements

To be considered for this role, candidates must meet the following criteria:

• Education: A degree in B.Pharm, M.Pharm, Life Sciences, or a related field within Clinical Research.
• Experience: A minimum of 3 years of professional experience in a Quality Assurance role within the clinical research or pharmacovigilance industry.
• Technical Proficiency: A strong, working knowledge of ICH-GCP guidelines, clinical trial regulatory frameworks, and audit methodologies.
• Analytical Skills: Demonstrated ability to manage multiple QA workflows, document control processes, and identify discrepancies in complex datasets.
• Soft Skills: Strong communication skills, exceptional attention to detail, and the ability to maintain composure and precision while handling multiple tasks simultaneously.

Preferred Skills

While not mandatory, the following qualifications will be considered an asset:

• Prior experience conducting clinical QA audits.
• In-depth knowledge of current pharmacovigilance regulations.
• Demonstrated capability in maintaining rigorous documentation accuracy in high-pressure environments.

Benefits and Compensation

Clinvigilant offers a supportive environment designed to help you grow professionally while contributing to meaningful work in clinical research.

• Salary Range: Competitive compensation package ranging from ₹4,00,000 to ₹7,50,000 per annum, commensurate with experience and expertise.
• Growth: Performance-based career advancement opportunities.
• Professional Development: Exposure to sophisticated regulatory systems and advanced clinical research quality management practices.

How to Apply

We invite qualified and enthusiastic candidates to apply for this position. To submit your application, please send your updated CV and a brief cover letter outlining your relevant experience to:

Email: [email protected]

Please include “QA Professional Application – Ahmedabad” in the subject line of your email. We look forward to reviewing your credentials and exploring how your skills can contribute to our team’s success.

Clinvigilant is an equal opportunity employer.