HOD - Quality Control / Quality Assurance

Jobitus; Bharuch District; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Jobitus in India is seeking a QC/QA professional to lead the QC team, ensure compliance with cGMP, GLP, FDA and regulatory requirements, and review analytical data and batch release documents.

The role involves investigations (OOS/OOT/deviations), stability studies, calibration, method validation/transfer, audits, and collaboration with QA, Production and Regulatory Affairs to maintain audit readiness and support regulatory inspections.

Qualifications

• Ensure compliance with cGMP, GLP, FDA and regulatory requirements.
• Lead QC team operations, daily task allocation and technical troubleshooting.
• Review analytical raw data, HPLC/GC audit trails, SOPs and batch release documents.
• Lead investigations related to OOS, OOT, deviations and incidents, including RCA and CAPA.
• Manage stability studies, instrument calibration, analytical method validation/transfer and cleaning verification.
• Maintain reference standards and laboratory documentation.
• Train and guide QC analysts and reviewers.
• Coordinate with QA, Production and Regulatory Affairs for quality-related activities.
• Support regulatory inspections and maintain audit readiness.

Responsibilities

• Ensure compliance with cGMP, GLP, FDA and regulatory requirements.
• Lead QC team operations, daily task allocation and technical troubleshooting.
• Review analytical raw data, HPLC/GC audit trails, SOPs and batch release documents.
• Lead investigations related to OOS, OOT, deviations and incidents, including RCA and CAPA.
• Manage stability studies, instrument calibration, analytical method validation/transfer and cleaning verification.
• Maintain reference standards and laboratory documentation.
• Train and guide QC analysts and reviewers.
• Coordinate with QA, Production and Regulatory Affairs for quality-related activities.
• Support regulatory inspections and maintain audit readiness.

Skills

HPLC/GC/UV-Vis

QMS/GMP compliance

SAP Laboratory modules

USFDA/EDQM/ANVISA audits

Microbiology knowledge

English communication

Job description

Key Responsibilities:

• Ensure compliance with cGMP, GLP, FDA and regulatory requirements.


• Lead QC team operations, daily task allocation and technical troubleshooting.


• Review analytical raw data, HPLC/GC audit trails, SOPs and batch release documents.


• Lead investigations related to OOS, OOT, deviations and incidents, including RCA and CAPA.


• Manage stability studies, instrument calibration, analytical method validation/transfer and cleaning verification.


• Maintain reference standards and laboratory documentation.


• Train and guide QC analysts and reviewers.


• Coordinate with QA, Production and Regulatory Affairs for quality-related activities.


• Support regulatory inspections and maintain audit readiness.

Technical Skills:

• Hands-on experience with HPLC, GC, UV-Vis and wet chemistry.


• Strong knowledge of QMS, QRM, GMP and laboratory compliance.


• Working knowledge of SAP Laboratory modules.


• Experience facing USFDA / EDQM / ANVISA audits is mandatory.


• Microbiology knowledge will be an added advantage.


• Good written and verbal English communication skills.