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.