Executive – Quality Assurance & Pharmacovigilance

DigitalCube Consultancy; Mumbai; On-site; INR 600,000 - 900,000; Full time

Job summary

DigitalCube Consultancy seeks an Executive – Quality Assurance & Pharmacovigilance to support QA and PV activities, maintain quality documentation, and assist with adverse event reporting.

The role involves ensuring GMP compliance, reviewing deviations, CAPA, OOS, change controls, and participating in audits and inspections. If you have 1–3 years in pharmaceutical QA/PV and a related degree, apply to join a 6-day workweek, office-based team.

Qualifications

• Knowledge of Quality Assurance and Pharmacovigilance.
• Understanding of GMP and Schedule M requirements.
• SOP management and quality documentation.
• Knowledge of CAPA, deviations, OOS, and change control.
• Internal audit and product verification.
• AE/ADR case processing and reporting.
• Understanding of PSUR and PSMF documentation.
• Working knowledge of MS Office.

Responsibilities

• Maintain SOPs, specifications, and quality records.
• Assist in deviation management, CAPA, OOS, change control, and product complaint investigations.
• Support internal audits, vendor qualification, and quality compliance activities.
• Review quality documents and track closure of quality-related issues.
• Assist during regulatory inspections and customer audits.
• Conduct warehouse visits for product verification.
• Receive, review, and process Adverse Event (AE) and Adverse Drug Reaction (ADR) reports.
• Maintain pharmacovigilance records, databases, and trackers.
• Assist with case processing, follow-ups, and regulatory reporting.
• Support PSUR preparation and PSMF documentation.
• Assist with pharmacovigilance compliance activities, audits, and inspections.

Skills

Quality Assurance

Pharmacovigilance

GMP

Schedule M

SOP Management

CAPA

Deviations

OOS

Change Control

Internal Audit

AE/ADR processing

PSUR/PSMF

MS Office

Education

B.Pharm / M.Pharm / Pharm.D / Life Sciences

Job description

Executive – Quality Assurance & Pharmacovigilance

Designation: Executive – Quality Assurance & Pharmacovigilance

Experience: 1–3 Years

Qualification: B.Pharm / M.Pharm / Pharm.D / Life Sciences

Work Mode: Work from Office, 6 Days a Week

Job Summary

The role involves supporting Quality Assurance and Pharmacovigilance activities, maintaining quality documentation, assisting with adverse event reporting, and supporting compliance with applicable pharmaceutical quality and drug safety guidelines.

Key Responsibilities

Quality Assurance

Maintain SOPs, specifications, and quality records.

Assist in deviation management, CAPA, OOS, change control, and product complaint investigations.

Support internal audits, vendor qualification, and quality compliance activities.

Review quality documents and track closure of quality-related issues.

Assist during regulatory inspections and customer audits.

Conduct warehouse visits for product verification.

Receive, review, and process Adverse Event (AE) and Adverse Drug Reaction (ADR) reports.

Maintain pharmacovigilance records, databases, and trackers.

Assist with case processing, follow-ups, and regulatory reporting.

Support PSUR preparation and PSMF documentation.

Assist with pharmacovigilance compliance activities, audits, and inspections.

Required Skills

Knowledge of Quality Assurance and Pharmacovigilance.

Understanding of GMP and Schedule M requirements.

SOP management and quality documentation.

Knowledge of CAPA, deviations, OOS, and change control.

Internal audit and product verification.

AE/ADR case processing and reporting.

Understanding of PSUR and PSMF documentation.

Working knowledge of MS Office.

Candidate Profile

Candidates with 1–3 years of relevant experience in pharmaceutical Quality Assurance or Pharmacovigilance and a degree in B.Pharm, M.Pharm, Pharm.D, or Life Sciences may apply.