Assistant General Manager - Corporate Quality Control

ARISTO PHARMACEUTICALS; Mumbai; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

ARISTO PHARMACEUTICALS in Mumbai seeks a seasoned Corporate QC leader to harmonize analytical quality systems across manufacturing sites. You will provide strategic guidance to site QC teams for compliance, analytical excellence, and continuous improvement.

The role requires hands-on management of global regulatory requirements and oversight of data integrity, CAPA, Change Control, and risk assessments, with a focus on maintaining pharmaceutical quality across the product lifecycle.

Qualifications

• B.Pharm/M.Pharm/M.Sc. in a related field with strong QC exposure.
• 12–20 years of experience in Pharmaceutical Quality Control/Corporate QC/Analytical QA.
• Hands-on experience with global regulatory requirements and inspections (USFDA, EU GMP, MHRA, WHO-GMP).

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, STPs, GTPs, Analytical Data Sheets, 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 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 new 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.

Skills

Leadership

Communication

Analytical

Stakeholder management

Regulatory compliance

Data Integrity

Quality systems management

OOS/OOT investigations

CAPA & Change Control

Pharmacopeial compliance

Education

B.Pharm

M.Pharm

M.Sc. (Chemistry/Analytical Chemistry/Pharmaceutical Chemistry/Life Sciences)

Tools

LIMS

Empower

SAP

ERP

eQMS

Job description

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 new 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.