QUALITY ASSURANCE & PHARMACOVIGILANCE

VRINDA INTERNATIONAL; Maharashtra; On-site; INR 360,000 - 440,000; Full time

Job summary

Vrinda International is seeking a Quality Assurance & Pharmacovigilance Specialist to oversee integrity and safety standards across pharmaceutical and IT service operations. The role ensures regulatory compliance, risk management, and continuous improvement to safeguard patient safety and product efficacy.

The successful candidate will lead QA, pharmacovigilance activities, audit programs, CAPA, change control, and SOP development while upholding GMP guidelines in all relevant activities.

Qualifications

• Possess 1–3 years of relevant professional experience in QA and PV.
• Demonstrate proficiency in product verification and internal audits.
• Experience in change control and complaint management systems.
• Background in QA and pharmacovigilance methodologies.
• Knowledge of SOPs, CAPA processes, and GMP regulations.
• Familiarity with IT services context in pharmaceutical quality standards.

Responsibilities

• Conduct thorough product verification to ensure accuracy and compliance.
• Execute internal audits to evaluate operational effectiveness and improvements.
• Manage change control procedures and document impact assessments.
• Oversee complaint management systems and coordinate resolutions.
• Uphold QA principles across departments to maintain standards.
• Perform pharmacovigilance activities for adverse event detection and prevention.
• Develop and maintain SOPs to guide daily operations.
• Lead CAPA initiatives addressing root causes of non-conformities.
• Ensure strict GMP adherence in relevant activities.

Skills

Product Verification

Internal Audits

Change Control

Complaint Management

Quality Assurance

Pharmacovigilance

SOPs

CAPA

GMP

Job description

Quality Assurance & Pharmacovigilance Specialist

Summary

We are seeking a dedicated professional to oversee the integrity and safety standards of our pharmaceutical and IT service operations. This pivotal role is responsible for ensuring that all products and processes adhere to rigorous regulatory frameworks and internal quality protocols. The successful candidate will play a critical part in maintaining compliance, managing risk, and driving continuous improvement initiatives to safeguard patient safety and product efficacy throughout the lifecycle.

Responsibilities

• Conduct thorough product verification processes to ensure accuracy and compliance with established standards.
  
• Execute internal audits to evaluate operational effectiveness and identify areas for potential improvement.
  
• Manage change control procedures, assessing the impact of modifications and ensuring proper documentation.
  
• Oversee complaint management systems, investigating reports and coordinating resolutions efficiently.
  
• Uphold Quality Assurance principles across all departments to maintain high operational standards.
  
• Perform Pharmacovigilance activities, including the detection, assessment, understanding, and prevention of adverse effects.
  
• Develop, implement, and maintain Standard Operating Procedures (SOPs) to guide daily operations.
  
• Lead Corrective and Preventive Action (CAPA) initiatives to address root causes of non-conformities.
  
• Ensure strict adherence to Good Manufacturing Practices (GMP) in all relevant activities.

Requirements

• Possess a minimum of 1 to 3 years of relevant professional experience in the field.
  
• Demonstrate strong proficiency in Product Verification and Internal Audits.
  
• Show expertise in managing Change Control and Complaint Management systems.
  
• Have a solid background in Quality Assurance and Pharmacovigilance methodologies.
  
• Be well-versed in creating and enforcing SOPs, CAPA processes, and GMP regulations.
  
• Ability to work within the IT Services sector with a focus on pharmaceutical quality standards.
  
• Competitive salary package of ₹4 LPA commensurate with experience.