Quality Assurance/Quality Control

Gpatindia; Mumbai; On-site; INR 1,200,000 - 1,600,000; Full time

Job summary

Gpatindia seeks a Specialist Quality Assurance Auditor - Innovative Medicine to lead R&D QA audits and support regulatory inspections. The role requires PV experience, GVP auditing, and the ability to coordinate cross-functional teams in a global setting.

The candidate will drive quality assurance activities, assist in training materials, and contribute to projects ensuring compliance with regulatory standards and company policies.

Qualifications

• Requires strong analytical thinking and attention to detail in safety data and compliance reviews.
• Excellent communication skills to influence stakeholders.
• Ability to manage multiple audits and priorities in a global environment.
• Pharmacovigilance expertise and QA auditing experience in PV/GVP is preferred.

Responsibilities

• Leads planning, conduct and reporting of R&D Quality QA routine audits and supports non-routine audits across activities, data, facilities and processes to ensure compliance.
• Supports regulatory inspections in various roles to ensure inspection readiness.
• Completes assigned training to maintain readiness and may help prepare training materials.
• Participates in projects or teams; ensures priorities and timelines are met.
• Provides consultation to business partners on routine tasks and assists with non-routine issues to maintain a unified departmental position.
• Acts as SME/point of contact for PV auditing and regulatory compliance inquiries.

Skills

Analytical thinking

Attention to detail

Communication skills

Cross-functional collaboration

Prioritization

Education

Bachelor's degree in Life Sciences, Pharmacy, Medicine, or related discipline

Job description

Post Name

Specialist Quality Assurance Auditor - Innovative Medicine

Job Function

Quality

Job Sub Function

Quality Assurance

Job Description

Main responsibilities will include but are not limited to:

Auditing

Leads the planning, conduct and reporting of R&D Quality QA routine audits and supports non-routine audits of activities, data, internal facilities and processes in GxP/non-regulated areas to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements. Non-routine audits include Due Diligence, for cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope.

Ensures the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities.

Inspection Support

Supports regulatory inspections in various supporting roles.

Training & Development

Completes assigned training requirements in a timely manner to ensure inspection readiness at all times.

May assist in the preparation of training material if requested.

People Management

N/A

Project Management

Participates in projects or serves on teams, as assigned by supervisor.

Meets priorities, checkpoints and timelines for all aspects of work and projects to achieve adequate progress.

Subject Matter Expert / Point of Contact

Provides consultation to business partners on routine tasks with occasional supervision. Cooperates with business partners when contacted for compliance inquiries and seeks advice on non-routine and more complex issues to ensure a departmental unified position.

Job Requirements: (Pharmacovigilance Auditor Focus)

Education & Experience

• Bachelor's degree in Life Sciences, Pharmacy, Medicine, or related discipline.


• Minimum 2 years of experience in Pharmacovigilance (PV) within the pharmaceutical or biotech industry.


• Proven hands-on experience in PV operations (e.g., case processing, signal detection, risk management, safety surveillance) or other PV-related roles.


• 2+ years of QA auditing experience, specifically in Pharmacovigilance / GVP audits (internal, external, or vendor audits) ispreferred.

Pharmacovigilance Expertise (Critical Requirement)

• Knowledge of Pharmacovigilance regulations and guidelines, including EU Good Pharmacovigilance Practices and Health Authority requirements in Asian countries


• Understanding of end-to-end PV processes, including:

• Individual Case Safety Report management


• Aggregate reporting (i.e. PSUR/PBRER, DSUR)


• Product risk management and implementation of risk minimization activities


• Vendor oversight and PV compliance models


• Experience auditing PV systems, processes, databases, and service providers ispreferred.

Skills & Competencies

• Strong analytical thinking and attention to detail, particularly in safety data and compliance reviews.


• Excellent communication skills, with the ability to influence and challenge stakeholders constructively.


• Ability to manage multiple audits and priorities in a fast-paced, global environment.


• High level of integrity, professionalism, and objective judgment in sensitive or high-impact audit situations.


• Proven ability to work cross-functionally and across geographies.

Preferred Skills

• Business Alignment


• Business Behavior


• Coaching


• Compliance Management


• Continuous Improvement


• Data Analysis


• Detail-Oriented


• Goal Attainment


• Human-Centered Design


• Internal Controls


• Issue Escalation


• Problem Solving


• Process Oriented


• Quality Control (QC)


• Quality Management Systems (QMS)


• Quality Standards