Role & responsibilities

Job Title: Investigator Corporate Quality Assurance (CQA)

Experience: 8 to 10 years

Position: Assistant Manager To review and evaluate Quality Management System (QMS) investigations and compliance activities across manufacturing sites, ensuring adherence to GMP, global regulatory requirements, and internal quality standards. The role supports investigation excellence, audit readiness, trend analysis, CAPA effectiveness, and continuous quality improvement across all company sites.

Key Responsibilities
Investigation Review & Compliance Oversight (Deviation, OOS, OOT, laboratory incident and Market complaint)
Assess investigation quality, root cause determination, CAPA adequacy, and its effectiveness.
Visit to respective site for investigation and recurring events
Conduct CAPA verification activities at manufacturing sites for Investigation
Review and analyze periodic trend of Deviation, OOS, OOT, and laboratory incident.
Identify recurring quality events and systemic gaps.
Recommend additional corrective and preventive actions (CAPAs) based on trend evaluation.
Support regulatory inspections and audits across all manufacturing locations wrt Investigations.




Participate in planning and execution of site review activities to ensure perpetual audit readiness.
Assist sites in preparing responses and remediations related to regulatory observations and audit findings.
Review GMP-related industry trends, regulatory observations, warning letters, and US FDA 483 observations wrt Investigations.
Support preparation and execution of internal audits, supplier audits, and external inspections.
Review investigation reports and provide comments to ensure completeness, scientific rationale, and regulatory compliance.
Monthly meeting with all the sites for discussion of route cause and CAPA of complaints

Preferred candidate profile
Detail-oriented and quality-focused mindset.
Robust decision-making and judgment capabilities.
Ability to manage multiple priorities and meet timelines.
High integrity with a compliance-driven approach.
Proactive in identifying risks and driving sustainable solutions.
Effective stakeholder management and influencing skills across sites and functions.

📌 Investigator, Corporate Quality Assurance Navi Mumbai
🏢 Alkem Laboratories
📍 Navi Mumbai