Senior Associate, Quality Assurance

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.

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