Quality Assurance Specialist

Talent Leap Private Limited; Mumbai; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Talent Leap Private Limited in Mumbai is seeking a Medical Quality Assurance (MQA) professional with hands-on experience in Pharmacovigilance (PV) and Clinical Trial (CT) auditing to strengthening QA for PV and CT activities.

You will plan and conduct risk-based audits, review CAPAs, support inspections, and ensure timely audit reports. Travel up to 30% domestically and internationally is required. The role requires a Master’s degree and 2-5 years in pharma/CRO settings.

Qualifications

• Master’s Degree or equivalent in Pharmacy, Science or related field.
• 2-5 years of experience in Pharmaceutical or CRO setting.
• Mandatory experience in GCP/PV auditing.
• Strong knowledge of ICH GCP, EU GVP and applicable regulatory requirements.

Responsibilities

• Ensure PV and Clinical Trial activities comply with internal procedures, regulatory requirements and industry standards.
• Develop and implement QA policies and SOPs for PV and CT activities.
• Plan and conduct risk-based audits.
• Conduct PV system audits, affiliate audits, licensing partner audits and service provider audits.
• Conduct audits of clinical research teams and investigator sites for Phase 3 & 4 clinical trials.
• Review audit responses, CAPA and effectiveness checks.
• Support global inspection preparation and inspection management.
• Support licensing partner audits, including audit responses and CAPA.
• Ensure audit reports and corrective/preventive actions are completed within defined timelines.

Skills

PV auditing

GCP auditing

ICH GCP

Regulatory knowledge

Travel readiness

Education

Master’s degree in Pharmacy/Science

Job description

Job Title: Medical Quality Assurance (MQA)

Qualification

Master’s Degree or equivalent in Pharmacy, Science or a related field

Industry

Pharmaceutical / CRO

Job Description

We are hiring a Medical Quality Assurance (MQA) professional with experience in Pharmacovigilance (PV) and Clinical Trial (CT) auditing.

Key Responsibilities

• Ensure PV and Clinical Trial activities comply with internal procedures, regulatory requirements and industry standards.
• Develop and implement QA policies and SOPs for PV and CT activities.
• Plan and conduct risk-based audits.
• Conduct PV system audits, affiliate audits, licensing partner audits and service provider audits.
• Conduct audits of clinical research teams and investigator sites for Phase 3 & 4 clinical trials.
• Review audit responses, CAPA and effectiveness checks.
• Support global inspection preparation and inspection management.
• Support licensing partner audits, including audit responses and CAPA.
• Ensure audit reports and corrective/preventive actions are completed within defined timelines.

Required Skills & Experience

• 2-5 years of experience in a Pharmaceutical or CRO setting.
• Mandatory experience in GCP/PV auditing.
• Strong knowledge of ICH GCP, EU GVP and applicable regulatory requirements.
• Knowledge of clinical trial conduct.
• Ability to work independently and effectively in a multidisciplinary team.
• Willingness to travel domestically and internationally up to 30%.