Senior Associate, Quality Assurance

Requirements

• Bachelor's/Master's degree in Life Sciences or equivalent
• With at least 2 years relevant experience.

Additional Information

Primary Responsibilities: 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. To provide support for audits (regulatory, certification, client and vendor audits). Review of ClinChoice Global documents such as risk tracker, non-conformity forms etc. To analyze root causes and review/propose CAPAs/corrections. Identify areas of risk in liaison with operations team and develop risk mitigation program. Coordinate for system implementation/improvement of QMS related activities for all support functions. Ensure data security/privacy measures are implemented/ managed in the relevant delivery teams by providing trainings to the delivery leads and the team members. Participate in Management Review Meetings and follow up for the compliance of decisions made. Participate and implement system upgrades as per management requirement. To take up further responsibilities as assigned by reporting manager or management. Secondary Responsibilities: To serve as back up for all quality related functions or take up secondary responsibility as per requirement and training provided. Support in quality metrics management for projects. Review and analyze organizational level metrics as well as project engagement level metrics where applicable. QMS/ ISMS/ PIMS Responsibilities: Be aware of and comply with the QMS/ ISMS & PIMS Policy. Participate and contribute to data protection impact assessments, risk assessments as applicable. Report any potential or actual security breaches to the regional and/or global DPO & security incidents to CISO/ applicable distribution list. Contribute towards achievement of Quality Objectives including QMS, ISMS and PIMS. To take up any further responsibilities as assigned by reporting manager or Management as per training provided.

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