Quality Assurance Specialist

Job Description Job Title: Specialist/Lead Quality Assurance Employment Type: Full time Location: Bengaluru, India

About ClinChoice ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis. Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally. We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision.

Responsibilities
Develop and maintain policies, SOPs, and Work instructions in compliance with regulatory and industry standards and the company's policies and procedures. Responsible for monitoring, investigating, and assessing clinical s & pharmacovigilance related processes at global and regional levels for consistency and compliance with applicable laws and regulatory requirements. Define quality strategy for existing and new programs. Partner closely with project managers, leaders, and internal and external partners alike to ensure an end-to-end approach for quality management. ¢ Identify areas of risk (Risk Assessment) in liaison with Operations and develop appropriate audit program ¢ Own the end-to-end Client Audit/Inspections activities for sites and scope ¢ Establish quality and compliance activities during transition for new deals. ¢ Ensure data security/privacy measures are implemented in deal teams, by the delivery leads and deal compliance representatives. ¢ Implementation and monitoring of Information security and Quality management system controls by utilizing expertise on ISO 9001 and 27001 is mandatory ¢ Analysis of RCA&CAPA, monitor effectiveness checks for the same ¢ Client feedback: collection, collation, analysis and recommendation for improvement on client requirements. ¢ Support in CSV activities at iMEDGlobal & in maintenance and improvement of global BCP and DR process. ¢ Support in organization level data across all the functions globally to develop a dashboard specific to respective department & coordinate with leadership to support in Quality metrics

management for projects/deals. ¢ Work with Global Clients in for Quality Consulting assignments; short/long term Candidate Profile ¢ Post-Graduate / Graduate in Pharmacy or Lifesciences. ¢ Excellent verbal communication and strong writing skills in English. ¢ Accountability and responsibility for delivery of quality results which support internal and external needs of the project. ¢ Ability to work independently and collaborate with team to meet project requirements.