QA / QC Manager role in Clinical Research / Contract Research (1-3 Yrs)

Role Summary:
We are seeking a motivated QA / QC Manager with 1-3 years of experience to join our dynamic team in Surat. This role is crucial for ensuring the quality and compliance of our clinical research operations. The ideal candidate will have a strong understanding of quality management systems and regulatory requirements within the pharmaceutical and biotechnology sectors. This position is suitable for individuals with any postgraduate degree seeking to advance their career in quality assurance within the clinical research industry.

Key Responsibilities:
- Develop, implement, and maintain Quality Management Systems (QMS) in accordance with GxP guidelines (GLP, GCP, GMP).
- Conduct internal and external audits to ensure compliance with regulatory standards and company SOPs.
- Review and approve quality-related documents, including SOPs, batch records, validation protocols, and reports.
- Investigate deviations, out-of-specification (OOS) results, and customer complaints, and implement corrective and preventive actions (CAPAs).
- Monitor and assess quality metrics and trends to identify areas for continuous improvement.
- Train personnel on quality standards, procedures, and regulatory requirements.
- Participate in regulatory inspections and client audits, providing necessary documentation and support.
- Ensure that all quality control activities are performed accurately and efficiently.
- Collaborate with cross-functional teams to resolve quality issues and promote a culture of quality throughout the organization.