Quality Analyst - CAPA

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent thats bold, industrious, and nimble. With Indegene, you gain 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, check out www.careers.indegene.com

Looking to jump-start your career

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. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegenes high-speed growth.

We are purpose-driven. 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.

If this excites you, then apply below.

Purpose: The PV Compliance team member is responsible for raising process deviations, review, documentation, monitoring and follow up of process deviations and implementation of CAPA, Audit and Inspection readiness along with doing general project coordination for Global Head PV.

Responsibilities:

• 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. This monitoring will require contact with CAPA owners prior to the due date to ensure CAPAs remain on track.
• 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.

Relationship Management

• Working within PV team globally and cross-functionally.
• Interactions with vendors/service providers for PV activities.

Process Improvement / Standardization

• Participate in streamlining Global integration project under supervision of Global Head of PV.

Desired Skills & Competencies

• Ideally M Pharm but BPharm is a must.
• Knowledge of case processing and aggregate reports is a must with a minimum of 4-5 years of work experience in total in PV
• Good working knowledge of PV regulations including FDA, EU & local requirements.
• Performs timely coordination of safety information dissemination with minimal direct supervision.
• Excellent teamwork and interpersonal skills.
• Excellent time management and organisational skills.
• Good knowledge of computer applications and software, including MS Word, Excel, PowerPoint etc.

Experience: 1 year - 5 years

Education: B. Pharma/ M. Pharma

Work Location: Bangalore

Work mode: Work from office

EQUAL OPPORTUNITY

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, the candidates merit and qualification.

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.

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