Senior Qa Manager

Ruchita Hiraji Thakur Mumbai; Padra; On-site; INR 900,000 - 1,100,000; Full time

Job summary

Ruchita Hiraji Thakur Mumbai is seeking a Lead QA professional to head the Oncology OSD unit. The role requires ensuring quality system compliance, data integrity, and timely deviation investigations and CAPA.

Responsibilities include batch document review, change controls, validation support, and audit readiness. The ideal candidate will coordinate with production, QC, and RA to fulfill audit commitments and regulatory requirements.

Qualifications

• Must have hands-on experience with Oncology OSD GMP practices.
• Strong knowledge of quality systems and data integrity.
• Experience in deviation investigations and CAPA processes.
• Experience with validation and batch review.
• Ability to lead audits and coordinate teams across functions.

Responsibilities

• Lead QA team for Oncology OSD unit and maintain quality oversight.
• Manage Quality System and ensure compliance with regulatory standards.
• Review batch documentation and deviations/CAPA for release readiness.
• Coordinate change controls, validation activities, and document control.
• Prepare for regulatory audits and ensure audit readiness across sites.

Skills

Oncology OSD GMP

Quality systems

Data integrity

Deviation investigation and CAPA

Audit preparation and leadership

Job description

Lead QA Team for the Oncology OSD Unit, USFDA Approved, Manage Quality System, Batch Document Review, Deviations, CAPA, change controls, Regulatory Audits. Site Audit Readiness, Coordinate with Production, QC, RA for documentation, audit commitments

Required Candidate profile

• Oncology OSD GMP
• Quality Systems and data integrity
• Deviation investigation and CAPA
• validation and batch review
• Audit preparation and team leadership