Executive/Sr. Executive, QMS (Injectable Manufacturing)

Intas; Ahmedabad District; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Intas is seeking a QA professional to manage and monitor QMS activities, including deviations, CAPA, change controls, and OOS/OOT, while ensuring data integrity and cGMP compliance. You will coordinate investigation activities, prepare GMP documentation, and support audits across USFDA, EU GMP, MHRA, WHO, and other agencies.

The role requires strong knowledge of injectable QA systems, sterile processing, and regulatory guidelines, with experience in TrackWise, LMS, or EDMS.

Qualifications

• Must have pharma QA exposure with GMP/dGMP principles.
• Experience with deviations, CAPA, change control and OOS/OOT handling.
• Familiarity with data integrity concepts (ALCOA+).

Responsibilities

• Manage and monitor QMS activities including Deviations, CAPA, Change Controls, OOS, OOT, Risk Assessments, and Market Complaints.
• Review, track, and ensure timely closure of deviations and CAPAs.
• Coordinate investigation activities related to quality events and support root cause analysis.
• Prepare and review SOPs, protocols, reports, quality manuals, and other GMP documentation.
• Support qualification, validation, and quality risk management activities.
• Ensure compliance with cGMP requirements, data integrity guidelines, and regulatory standards.
• Participate in internal audits, self-inspections, and regulatory/customer audits.
• Monitor QMS metrics and prepare periodic management review reports.
• Conduct GMP training programs and maintain training compliance records.
• Support regulatory inspections by USFDA, MHRA, EU GMP, WHO, TGA, and other agencies.
• Review and maintain documentation related to sterile manufacturing processes and aseptic practices.
• Coordinate with Production, QC, QA, Engineering, Warehouse, and Validation teams for quality compliance.

Skills

Injectable QMS knowledge

Deviations handling

CAPA

Change control

OOS/OOT handling

Data integrity ALCOA+

QMS software experience

Education

B.Pharm / M.Pharm / M.Sc. in life sciences

Tools

TrackWise

LMS

EDMS

Job description

Key Responsibilities :

• Manage and monitor QMS activities including Deviations, CAPA, Change Controls, OOS, OOT, Risk Assessments, and Market Complaints.
• Review, track, and ensure timely closure of deviations and CAPAs.
• Coordinate investigation activities related to quality events and support root cause analysis.
• Prepare and review SOPs, protocols, reports, quality manuals, and other GMP documentation.
• Support qualification, validation, and quality risk management activities.
• Ensure compliance with cGMP requirements, data integrity guidelines, and regulatory standards.
• Participate in internal audits, self-inspections, and regulatory/customer audits.
• Monitor QMS metrics and prepare periodic management review reports.
• Conduct GMP training programs and maintain training compliance records.
• Support regulatory inspections by USFDA, MHRA, EU GMP, WHO, TGA, and other agencies.
• Review and maintain documentation related to sterile manufacturing processes and aseptic practices.
• Coordinate with Production, QC, QA, Engineering, Warehouse, and Validation teams for quality compliance.

Educational Qualification

• B.Pharm / M.Pharm / M.Sc. (Microbiology, Biotechnology, Chemistry or relevant life science discipline)

Required Skills

• Strong knowledge of Injectable Quality Systems and cGMP requirements.
• Experience in Deviation, CAPA, Change Control, OOS/OOT handling.
• Understanding of Data Integrity (ALCOA+) principles.
• Familiarity with sterile manufacturing and aseptic processing requirements.
• Knowledge of USFDA, EU GMP, MHRA, WHO, and PIC/S guidelines.
• Good documentation and investigation skills.
• Proficiency in TrackWise, LMS, EDMS, or similar QMS software will be preferred.

Preferred Experience

• Experience in regulated pharmaceutical manufacturing facilities.
• Exposure to regulatory inspections and audit management.
• Experience in sterile injectable or parenteral manufacturing plants.