Role & responsibilities
Lead Corporate QC initiatives for harmonization and standardization of analytical quality systems across manufacturing sites.
Provide strategic guidance to site QC teams for compliance, analytical excellence, and continuous improvement.
Review and approve analytical quality documents including:
Specifications
Standard Testing Procedures (STPs)
General Testing Procedures (GTPs)
Analytical Data Sheets
Analytical Method Validation and Transfer documents
Drive Change Control implementation related to analytical specifications, methods, and QC documentation.
Provide QC oversight for current product development, technology transfer, and product lifecycle management activities.
Review analytical method validation, method transfer, and verification protocols/reports.
Monitor and implement global pharmacopeial updates (IP, USP, BP, EP, JP) and ensure regulatory compliance.
Support and lead regulatory inspections, customer audits, and corporate audits related to QC activities.
Ensure effective management of QC-related quality systems including OOS/OOT, Deviations, CAPA, Change Control, Risk Assessments, and Data Integrity.
Review critical investigations and ensure robust root cause analysis and effective CAPA implementation.




Review and approve QC-related documents including MFC, MPC, PDR, specifications, analytical protocols, and current product documentation.
Provide oversight for vendor qualification, third-party laboratory audits, and external testing compliance.
Mentor and develop QC teams while promoting a strong culture of quality and compliance.

Preferred candidate profile
Qualification: B.Pharm / M.Pharm / M.Sc. (Chemistry / Analytical Chemistry / Pharmaceutical Chemistry / Life Sciences).
Experience: 1220 years of experience in Pharmaceutical Quality Control / Corporate Quality Control / Analytical Quality Assurance.
Solid experience in managing analytical quality systems at corporate or multi-site level.
Hands-on experience with global regulatory requirements and inspections (USFDA, EU GMP, MHRA, WHO-GMP, PIC/S).
Strong knowledge of
cGMP & GLP requirements
ICH Guidelines
Data Integrity (ALCOA+)
Analytical Method Validation & Transfer
OOS/OOT Investigations
CAPA & Change Control
Pharmacopeial compliance
Experience with QC systems such as LIMS, Empower, SAP, ERP, or eQMS will be preferred.
Excellent leadership, communication, analytical, and stakeholder management skills.

📌 Assistant General Manager Corporate Quality Control Mumbai
🏢 Aristo pharmaceuticals
📍 Mumbai