Assistant Manager / Deputy Manager - Quality Control

Acme Formulation; Solan; On-site; INR 400,000 - 700,000; Full time

Job summary

Acme Formulation in Solan, Himachal Pradesh seeks a Quality Systems Specialist to manage QMS activities, perform risk assessments, review SOPs, and support grievance handling. You will oversee CAPA review and implementation, lead root cause investigations, monitor calibrations and maintenance, ensure data integrity, and drive continuous improvement through documented plans.

This role requires precise documentation, collaboration with cross-functional teams, and adherence to regulatory standards

Responsibilities

• Manage QMS activities: Change Control, Deviation, CAPA, OOS, OOT, Lab Events.
• Conduct Risk Assessments, SOP reviews, and assist in grievance handling.
• Document & review: Specifications, SOPs, Test Data Sheets, Analytical Test Reports, and Master documents.
• Review Method Validation Protocols & Reports.
• Monitor calibration and preventive maintenance schedules.
• Initiate procurement of impurity/reference standards, chemicals, reagents, columns, and laboratory glassware.
• Develop and implement site policies and procedures ensuring regulatory compliance.
• Supervise deviation and CAPA review, approval, and implementation.
• Create QC goals, objectives, and metrics to drive continuous improvement.
• Ensure data integrity systems are in place with frequent checks and challenge tests.
• Lead root cause investigations.
• Prepare experimental plans during investigations.
• Implement CAPA parameters post-investigation.
• Verify CAPA effectiveness.

Job description

• Manage QMS activities: Change Control, Deviation, CAPA, OOS, OOT, Lab Events.
• Conduct Risk Assessments, SOP reviews, and assist in grievance handling.
• Document & review: Specifications, SOPs, Test Data Sheets, Analytical Test Reports, and Master documents.
• Review Method Validation Protocols & Reports.
• Monitor calibration and preventive maintenance schedules.
• Initiate procurement of impurity/reference standards, chemicals, reagents, columns, and laboratory glassware.
• Develop and implement site policies and procedures ensuring regulatory compliance.
• Supervise deviation and CAPA review, approval, and implementation.
• Create QC goals, objectives, and metrics to drive continuous improvement.
• Ensure data integrity systems are in place with frequent checks and challenge tests.
• Lead root cause investigations.
• Prepare experimental plans during investigations.
• Implement CAPA parameters post-investigation.
• Verify CAPA effectiveness.