Executive - Corporate Quality Assurance

Aristo Pharmaceuticals Pvt. Ltd.; Mumbai; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Aristo Pharmaceuticals Pvt. Ltd. in Mumbai seeks an Executive / Senior Executive Corporate Quality Assurance (CQA) to strengthen our Corporate Quality function.

The role drives QMS, ensures regulatory compliance across manufacturing sites, supports audit readiness, and promotes harmonized quality practices. You will lead SOPs, CAPA, change control, investigations, and cross-functional collaboration with Manufacturing, R&D, Regulatory Affairs, and IT systems like SAP, ERP, and eQMS.

Qualifications

• B.Pharm / M.Pharm / M.Sc. (Chemistry, Microbiology, Biotechnology, or Life Sciences).
• 5-10 years in Corporate Quality Assurance or quality systems in pharma.
• Exposure to USFDA, EU GMP, MHRA, WHO-GMP or PIC/S preferred.
• Strong knowledge of cGMP, GDP, ICH guidelines, data integrity.
• Hands-on CAPA, Change Control, Deviations, OOS/OOT, risk management, validation.
• Experience handling regulatory inspections and audits.
• Familiarity with SAP, ERP, eQMS or similar systems.
• Excellent analytical, investigation, communication, and stakeholder management.
• Ability to work across multiple sites and cross-functional teams.

Responsibilities

• Drive QMS harmonization and implementation across manufacturing sites.
• Prepare, review, and implement SOPs for QMS, Validation, Change Control, CAPA, and training.
• Coordinate self-inspections/internal audits and closure of observations.
• Manage market complaints, recalls, and related investigations.
• Review change controls, deviations, OOS/OOT, CAPAs, and related documenation.
• Lead regulatory inspections, customer audits and audit readiness.
• Collaborate with Manufacturing, R&D, Regulatory Affairs and IT for tech transfer and quality initiatives.
• Support SAP, ERP, eQMS and other quality digital systems management.

Skills

Quality mindset

Analytical skills

Investigation skills

Communication skills

Stakeholder management

Cross-functional collaboration

Education

B.Pharm / M.Pharm / M.Sc.

Tools

SAP

ERP

eQMS

Job description

Job Summary

We are looking for a dynamic and experienced Executive / Senior Executive Corporate Quality Assurance (CQA) to strengthen our Corporate Quality function. The role involves driving Quality Management Systems (QMS), ensuring regulatory compliance across manufacturing sites, supporting audit readiness, and promoting harmonized quality practices across the organization.

Role & responsibilities

• Drive harmonization and implementation of Quality Management Systems (QMS) across manufacturing sites.
• Prepare, review, and implement SOPs related to QMS, Validation, Qualification, Change Control, CAPA, Training Management, and other quality systems.
• Conduct and coordinate periodic self-inspections/internal audits and ensure timely closure of observations.
• Manage Market Complaints, Product Recall activities, and associated investigations.
• Review and monitor Change Controls, Deviations, OOS, OOT, CAPAs, and other quality system elements.
• Ensure robust investigation practices and drive effective root cause analysis and CAPA implementation across sites.
• Coordinate with Manufacturing, R&D, Regulatory Affairs, and other cross-functional teams for new product development, technology transfer, and quality initiatives.
• Support implementation and management of SAP, ERP, eQMS, and other quality-related digital systems.
• Manage GMP and Quality training programs, including conducting training sessions and ensuring training compliance.
• Review and approve quality documents, including SOPs, MFC, MPC, PDR, validation documents, and new product documentation.
• Support and lead regulatory inspections, customer audits, and internal audits while ensuring continuous audit readiness.
• Initiate, monitor, and close Global CAPAs arising from audit observations and quality events.
• Conduct vendor qualification and third-party audits to ensure supplier compliance with regulatory and company standards.

Preferred candidate profile

• B.Pharm / M.Pharm / M.Sc. (Chemistry, Microbiology, Biotechnology, or Life Sciences).
• 5-10 years of experience in Corporate Quality Assurance, Quality Systems, or Quality Assurance in the pharmaceutical industry.
• Exposure to regulated markets such as USFDA, EU GMP, MHRA, WHO-GMP, or PIC/S will be preferred.
• Strong knowledge of cGMP, GDP, ICH Guidelines, Data Integrity, and pharmaceutical quality systems.
• Hands-on experience in CAPA, Change Control, Deviations, OOS/OOT, Risk Management, Validation, and Documentation.
• Experience handling regulatory inspections and customer audits.
• Familiarity with SAP, ERP, eQMS, or similar quality management systems.
• Excellent analytical, investigation, communication, and stakeholder management skills.
• Ability to work collaboratively across multiple manufacturing sites and cross-functional teams.