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 new 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.
- Strong 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