ITQA and CSV Compliance Specialist

4 weeks ago

Bengaluru, Karnataka, India Syngene Full time

Job Title: ITQA and CSV Compliance Specialist

About Syngene:

Incorporated in 1993, Syngene International Ltd. is a global discovery, development, and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries. Our innovative culture is driven by the passion of our 4240-strong team of scientists who work with clients worldwide to solve scientific problems, improve R&D productivity, speed up time to market, and lower the cost of innovation.

Job Purpose:

The ITQA and CSV Compliance Specialist will ensure compliance with data integrity policy and identify the cause of non-compliance. They will act as a validation engineer during system upgrades and strategic initiatives, conduct regular system hygiene checks to identify system gaps, and coordinate with IT-SMEs or service providers to streamline workflows and enhance EQMS Trackwise functionalities.

Key Responsibilities:

  • Ensure compliance with safety policies, procedures, and requirements, identifying causes of non-compliance.
  • Ensure compliance with Data Integrity Policy, identifying causes of non-compliance.
  • Ensure compliance with SOPs and approved instructions, identifying causes of non-compliance.
  • Act as a validation engineer during system upgrades and strategic initiatives.
  • Conduct regular system hygiene checks, identifying system gaps and feasibility for process improvements.
  • Coordinate with IT-SMEs or service providers to streamline workflows and enhance EQMS Trackwise functionalities.
  • Prepare and review Software Validation Deliverables to comply with regulatory guidelines.
  • Update project status reports for internal Quality review meetings.
  • Provide training and support to end-users on EQMS functionalities, best practices, and compliance.
  • Manage User Access and address user concerns related to Documentum processes.
  • Handle Change Control, Deviation, CAPA, and Audit management related to the EQMS Trackwise system.
  • Review the requalification status and update the CSV applications list periodically.
  • Ensure overall adherence to safe practices and procedures for oneself and aligned teams.
  • Manage vendor qualifications, review quality agreements, and maintain validation data.
  • Coordinate system upgrades and enhancements and prepare and review validation documentation.

Requirements:

  • M.Sc./Pharmacy degree
  • Good communication skills and experience in the pharma industry
  • 5-10 years of experience

Equal Opportunity Employer:

Syngene is an equal opportunity employer and provides reasonable accommodations for qualified individuals with disabilities.

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