Quality Assurance Specialist

2 weeks ago

Bengaluru, Karnataka, India Indegene Full time

Indegene is a technology-led healthcare solutions provider driven by its purpose to empower healthcare organizations to be future-ready. With accelerated, global growth opportunities for bold, industrious, and nimble talent, the company offers a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy.

To explore exciting opportunities at the convergence of healthcare and technology, visit www.careers.indegene.com

We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience where you will not only work at the exciting intersection of healthcare and technology but also be mentored by some of the most brilliant minds in the industry.

We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work.

Job Description:
  • Act as SME for deviation and CAPA handling activities during audit and regulatory authority inspections, as needed.
  • Collate all CAPA from internal QA audit and Health Authority Inspection and maintain in a summary spreadsheet.
  • Review the deviations and CAPA for completeness.
  • Follow up on open deviations/CAPA with CAPA owners to ensure completion within agreed timelines.
  • Liaise with country affiliates as necessary to receive updates on progress of CAPA for local process deviations and as a result of internal audit/external inspection
  • Work closely with the PV Quality & Compliance Lead to ensure oversight of deviations and CAPAs and that summary data is available for presentation at the monthly compliance meeting.
  • Ensure deviation and CAPA data is available in a format which can be easily included in the PSMF.
  • Ensure that information concerning closed deviations/CAPA are appropriately archived.
  • Filing and Archiving: Maintain PV shared folders for safety information, and maintain document security and integrity by filing documents securely on site or sending files to archive.
  • Provide data for internal compliance meetings, monthly report and for inclusion in the PSMF as required
  • Support for PV QMS: Support the development and revision of department SOPs and work instructions. Also participate in the review of cross-functional SOPs which include reference to PV activities.
  • Support during Audit & Inspection by collating and providing PV relevant data.
  • PV System Health: Conducts a periodic review of e.g., sample ICSRs, aggregate reports and/or some specific reports/deliverables (SDEA compliance) where we see quality issues, to ensure operational deliveries are as per required internal standards.
  • Perform project coordination activities for Global Head PV.

Our team operates globally and requires strong communication skills with a focus on teamwork and excellent interpersonal relationships.

While working with us, you will have an opportunity to enhance your knowledge in case processing, aggregate reporting, and PV regulations including FDA, EU, and local requirements.

Indegene provides a competitive salary package for this role, estimated at ₹7-10 Lacs per annum based on the location and the qualifications of the successful candidate.

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