Quality Control (Injectables / Vaccines) – AGM

KeyBiz Dashboards Pvt Ltd; Hyderabad; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

KeyBiz Dashboards Pvt Ltd in Hyderabad is seeking a senior Quality Control leader to oversee the sterile injectables and vaccine QC functions, ensuring cGMP compliance and timely testing across multiple laboratories.

The role requires 15+ years in QC for sterile products, with responsibility for COAs, SOPs, CAPA, and data integrity, while guiding audits and regulatory inspections and mentoring the QC team.

Qualifications

• Minimum 15 years of experience in quality control for sterile injectables and vaccine manufacturing.

Responsibilities

• Lead and manage the QC function for sterile injectables and vaccine manufacturing.
• Oversee Chemistry, Microbiology, Environmental Monitoring, Sterility Testing, Stability, and Biological Testing laboratories.
• Review and approve analytical reports, COAs, specifications, protocols, SOPs, and laboratory documentation.
• Ensure timely testing and release of raw materials, packaging materials, in-process samples, finished products, and stability samples.
• Supervise sterility testing, endotoxin, particulate matter, microbial limit testing, bioburden testing, media fill, and environmental monitoring programs.
• Manage analytical method validation, method transfer, method verification, and stability studies per ICH guidelines.
• Review and investigate OOS, OOT, laboratory deviations, CAPA, change controls, and laboratory incidents.
• Ensure qualification, calibration, maintenance, and lifecycle management of laboratory equipment.
• Support internal audits, customer audits, and global regulatory inspections, ensuring timely closure of observations.
• Collaborate with QA, Manufacturing, Engineering, Validation, Regulatory Affairs, R&D, and Supply Chain teams to ensure product quality and regulatory compliance.
• Drive continuous improvement initiatives to enhance laboratory efficiency, compliance, and operational excellence.
• Lead, mentor, and develop QC teams through training, coaching, and performance management.

Skills

Quality Control

Sterile Injectables

Laboratory Testing

Job description

Key Responsibilities

• Lead and manage the Quality Control function for Sterile Injectables and Vaccine manufacturing.
• Oversee Chemical, Microbiology, Environmental Monitoring, Sterility Testing, Stability, and Biological Testing laboratories.
• Ensure compliance with cGMP, GLP, WHO-GMP, US FDA, EU GMP, MHRA, PIC/S, ICH, and Schedule M requirements.
• Review and approve analytical reports, Certificates of Analysis (COA), specifications, protocols, SOPs, and laboratory documentation.
• Ensure timely testing and release of raw materials, packaging materials, in-process samples, finished products, and stability samples.
• Supervise sterility testing, endotoxin (BET), particulate matter testing, microbial limit testing, bioburden testing, media fill support, and environmental monitoring programs.
• Manage analytical method validation, method transfer, method verification, and stability studies in accordance with ICH guidelines.
• Review and investigate OOS, OOT, laboratory deviations, CAPA, change controls, and laboratory incidents.
• Ensure qualification, calibration, maintenance, and lifecycle management of laboratory equipment.
• Ensure compliance with Data Integrity (ALCOA+) principles and laboratory documentation practices.
• Support internal audits, customer audits, and global regulatory inspections, ensuring timely closure of observations.
• Collaborate with QA, Manufacturing, Engineering, Validation, Regulatory Affairs, R&D, and Supply Chain teams to ensure product quality and regulatory compliance.
• Drive continuous improvement initiatives to enhance laboratory efficiency, compliance, and operational excellence.
• Lead, mentor, and develop QC teams through training, coaching, and performance management.

Location

Hyderabad

Qualifications

• Minimum 15 Years of experience in Quality Control for sterile injectables and vaccine manufacturing.