02 Oct
|
Dinero Solutions
|
Bandra West
02 Oct
Dinero Solutions
Bandra West
Job Summary To support Quality Assurance and Pharmacovigilance activities by ensuring compliance with
GMP requirements, quality systems, adverse event reporting, product complaint management,
and applicable regulatory guidelines.
Key Responsibilities
Quality Assurance
Maintain and control SOPs, specifications, and quality records.
Support deviation, change control, CAPA, OOS, and complaint investigations.
Assist in internal audits, vendor qualification, and compliance monitoring.
Review quality documentation and ensure timely closure of quality events.
Support regulatory inspections and customer audits.
Visit warehouse for product verification.
Pharmacovigilance
Receive, review, and process Adverse Event (AE) / Adverse Drug Reaction (ADR) reports.
Maintain pharmacovigilance records, databases, and trackers.
Support case processing, follow-up activities,
and regulatory reporting.
Assist in preparation of PSURs, PSMF documentation, and PV compliance activities.
Support pharmacovigilance audits and inspections.
Skills & Competencies
Knowledge of GMP, Schedule M, and Pharmacovigilance requirements.
Valuable documentation, investigation, and analytical skills.
Proficiency in MS Office applications.
Robust communication and teamwork abilities.
Attention to detail and compliance-oriented approach
Pay: ₹25,000.00 - ₹30,000.00 per month
Perks
Provident Fund
Application Question(s):
What is your current CTC & notice period?
Experience:
Pharma Quality Assurance: 1 year (Preferred)
Work Location: In person
📌 Executive – Quality Assurance & Pharmacovigilance Bandra West
🏢 Dinero Solutions
📍 Bandra West