Senior Associate, Quality Assurance

<p><strong>Primary Responsibilities:</strong></p> <ul> <li>To prepare, review and maintain Standard Operating Procedure, Work Instructions and policies in line with the requirements defined as per standards, guidelines, industry trends and internal policies. </li> <li>To provide support for audits (regulatory, certification, client and vendor audits). &nbsp;</li> <li>Review of ClinChoice Global documents such as risk tracker, non-conformity forms etc. </li> <li>To analyze root causes and review/propose CAPAs/corrections.   &nbsp;</li> <li>Identify areas of risk in liaison with operations team and develop risk mitigation program. </li> <li>Coordinate for system implementation/improvement of QMS related activities for all support functions. </li> <li>Ensure data security/privacy measures are implemented/ managed in the relevant delivery teams by providing trainings to the delivery leads and the team members. </li> <li>Participate in Management Review Meetings and follow up for the compliance of decisions made. </li> <li>Participate and implement system upgrades as per management requirement. &nbsp;</li> <li>To take up further responsibilities as assigned by reporting manager or management. &nbsp;</li> </ul> <p><strong>Secondary Responsibilities:</strong></p> <ul> <li>To serve as back up for all quality related functions or take up secondary responsibility as per requirement and training provided.  </li> <li>Support in quality metrics management for projects.   </li> <li>Review and analyze organizational level metrics as well as project engagement level metrics where applicable.  &nbsp;</li> </ul> <p><strong>QMS/ ISMS/ PIMS Responsibilities:</strong></p> <ul> <li>Be aware of and comply with the QMS/ ISMS &amp; PIMS Policy.  </li> <li>Participate and contribute to data protection impact assessments, risk assessments as applicable.  </li> <li>Report any potential or actual security breaches to the regional and/or global DPO &amp; security incidents to CISO/ applicable distribution list. </li> <li>Contribute towards achievement of Quality Objectives including QMS, ISMS and PIMS. </li> <li>To take up any further responsibilities as assigned by reporting manager or Management as per training provided. </li> </ul> <p><strong>Skills and Qualifications:</strong></p> <ul> <li>Bachelor's/Master's degree in Life Sciences or equivalent</li> <li>With at least 2 years relevant experience.&nbsp;</li> </ul> <p>&nbsp;</p>