Quality Design Assurance

CIEL HR; Bengaluru; On-site; INR 350,000 - 650,000; Full time

Job summary

CIEL HR is seeking a Quality Assurance (QA) Executive in Bengaluru to oversee IPQA checks, review MBR/BMR records, and ensure compliance with cGMP and regulatory standards. Freshers with B.Pharm/M.Pharm may apply for trainee roles and gain exposure to investigations, CAPA, and audits.

The role coordinates with Production, QA and Regulatory teams to resolve quality issues, participate in supplier and customer audits, and support data integrity and documentation requirements across QA processes.

Qualifications

• B.Pharm / M.Pharm is required or fresher with relevant pharmaceutical qualifications.
• Freshers may be considered for trainee roles in QA.
• Experience with IPQA activities and QA documentation is advantageous.

Responsibilities

• Perform in-process quality assurance (IPQA) checks during manufacturing and packaging activities.
• Conduct line clearance activities and ensure compliance with approved procedures.
• Review and approve BMR, BPR, SOPs, protocols and reports.
• Handle deviations, investigations, Change Controls, CAPA, OOS and OOT.
• Ensure compliance with cGMP, GDP, GLP and regulatory requirements.
• Monitor validation and qualification activities including equipment qualification (DQ/IQ/OQ/PQ).
• Participate in internal audits, customer audits and regulatory inspections.
• Review and maintain quality documentation and data integrity records.
• Coordinate with Production, QA, Engineering and Regulatory teams to resolve issues.
• Conduct GMP training and support continuous quality improvement initiatives.
• Support APQR/PQR activities and risk management programs.
• Ensure timely implementation and effectiveness of CAPA.

Skills

IPQA checks

BMR/BPR review

CAPA handling

OOS/OOT investigations

cGMP compliance

Regulatory inspections

Data integrity

QA documentation

Cross-functional teamwork

GMP training

Education

B.Pharm / M.Pharm

Job description

Role & responsibilities Position: Quality Assurance (QA) Executive

Department: Quality Assurance (QA)

Education:

B.Pharm / M.Pharm

Experience:

Freshers with relevant pharmaceutical qualifications may be considered for trainee roles

Key Responsibilities

• Perform in-process quality assurance (IPQA) checks during manufacturing and packaging activities.
• Conduct line clearance activities and ensure compliance with approved procedures.
• Review and approve Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), SOPs, protocols, and reports.
• Handle deviations, incidents, Change Controls, CAPA, OOS (Out of Specification), and OOT (Out of Trend) investigations.
• Ensure compliance with cGMP, GDP, GLP, and regulatory requirements.
• Monitor validation and qualification activities, including equipment qualification (DQ, IQ, OQ, PQ).
• Participate in internal audits, customer audits, and regulatory inspections.
• Review and maintain quality documentation and data integrity records.
• Coordinate with Production, Quality Control, Engineering, and Regulatory Affairs teams to resolve quality issues.
• Conduct GMP training and support continuous quality improvement initiatives.
• Support Annual Product Quality Review (APQR/PQR) activities and risk management programs.
• Ensure timely implementation and effectiveness of corrective and preventive actions (CAPA).

Preferred candidate profile