Assistant General Manager Quality Control

AP Management Consultants; Cuddalore; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

AP Management Consultants in India seeks a seasoned Quality Control Leader with 15+ years in pharmaceutical QC and strong managerial experience. The role focuses on strengthening QC lab systems, ensuring CGMP compliance, and leading method transfer and validation activities.

The candidate will oversee calibration, instrument qualification, and regulatory audits while guiding a team, improving processes, and ensuring timely product release in a fast-paced manufacturing environment.

Qualifications

• 15+ years in pharmaceutical QC with management experience.
• Strong administrative capabilities and team leadership.
• Deep knowledge of cGMP and regulatory audits.
• Experience with instrument calibration, maintenance, and qualification.

Responsibilities

• Strengthen and maintain QC lab quality systems per regulatory requirements.
• Oversee calibration, preventive maintenance, and qualification of plant instruments.
• Prepare protocols and reports for qualification and re-qualification.
• Review calibration procedures per pharmacopeia guidelines.
• Lead method transfer and method validations; ensure on-time release of samples.
• Review analytical records and approvals of materials and finished products.
• Conduct cGMP and cGLP training programs.
• Participate in internal and external GMP/GLP audits.

Skills

Quality Leadership

Administrative Skills

Lean Management

Energy Conservation

Safety Knowledge

Team Building

cGMP Knowledge

Regulatory Audits

Calibration Review

Method Transfer

Job description

Role & responsibilities

• 15+ years of experience as a Quality Control professional in the pharmaceutical manufacturing industry (Formulation / finished drug product), with a minimum five to seven years in managerial / leadership positions.
• Very good capability of Administrative skill.
• Lean management approach.
• Energy conservation knowledge.
• Safety & Environmental knowledge
• Team Builders, Expressing skill from team.
• To strengthen and maintain the quality systems in QC laboratory to meet the regulatory requirements.
• To responsible for review and to ensure routine and periodic calibration, preventive maintenance and qualification of instruments, equipments of the plant. Responsible for preparation of protocols and reports related to qualification and re-qualification of instruments and their execution. Responsible for review of calibration procedures to be in line with current pharmacopeia/guidelines.
• Responsible for method transfer and method validations, timely release of samples as per production schedule.
• To review and evaluate analytical records and subsequent approvals or rejection of starting materials, packaging materials, intermediates, bulk and finished products.
• Advanced knowledge of cGMP requirements, quality systems, applicable to the QC Operations
• Strong written, oral, interpersonal, and presentation skills and the ability to effectively interface with all levels of management and staff.
• Review of R&D documents (Product Development Report, Method Validation Reports, Drug Master File (DMF), master documents like Batch Manufacturing Records-BMRs, Specifications, Various batch related Protocols &Reports, including PVP & PVR) required for Dossier filing.
• Responsible for providing the troubleshooting support to analysts
• To conduct cGMP and cGLP training programmes.
• To ensure compliance for various GMP / GLP monitoring tools like internal quality audits, in process testing etc.
• To carry out active participation in the Regulatory audits, external and internal audits of Quality Control.
• Responsible for review of laboratory log books, formats, analytical data sheets as per GDP.
• Provide necessary regulatory inputs and clearances during the product development to the PDT and external development partners (CRO).
• Tracking of new regulatory guidance and provide inputs to the concerned stakeholders.
• Interaction with the related cross functions to address the requirement for dossier filing and addressing the deficiencies.

Preferred candidate profile

Male Candidate Preferred(Any Pharma industry)

Contact number: 9585499066

Mail ID: [e-mail]