Analytical QC Compliance Lead & Audit Expert

Syngene International Limited; Hinoba-an; On-site; PHP 1,657,000 - 2,386,000; Full time

Job summary

Syngene International Limited is seeking a Principal Scientist - Analytical to oversee QC compliance, data integrity, and regulatory audits in Bengaluru. The role focuses on ensuring inspection readiness, managing QMS, and driving improvements across analytical labs.

The candidate should have 8–10 years in pharma/biotech QC or CRO/CDMO settings, with expertise in cGMP/GLP and regulatory inspections. Strong writing and leadership are essential.

Qualifications

• Candidates must hold relevant life sciences degrees with 8–10 years in QC/compliance.
• Strong knowledge of cGMP/GLP, data integrity, and regulatory audits.
• Experience with regulatory inspections (FDA, MHRA, EMA) is preferred.

Responsibilities

• Ensure QC labs comply with cGMP, GDP and ALCOA+ data integrity standards.
• Lead regulatory and customer audits and coordinate audit responses.
• Maintain QMS including deviations, CAPA, and change control.
• Oversee data integrity reviews for chromatography systems and software.
• Provide training and maintain GMP awareness across the team.
• Drive continuous improvement and inspection readiness.

Skills

Regulatory compliance

Audit management

Data integrity

GxP knowledge

Education

MSc Chemistry

MPharm / BPharm

Life sciences qualification

Tools

EMPOWER CDS

LIMS

TrackWise

LabWare

SAP

Job description

Syngene International Limited is seeking a Principal Scientist - Analytical to oversee QC compliance, data integrity, and regulatory audits in Bengaluru. The role focuses on ensuring inspection readiness, managing QMS, and driving improvements across analytical labs.

The candidate should have 8–10 years in pharma/biotech QC or CRO/CDMO settings, with expertise in cGMP/GLP and regulatory inspections. Strong writing and leadership are essential.