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.

Skills and Qualifications:

• Bachelor's/Master's degree in Life Sciences or equivalent

• With at least 2 years relevant experience.