Quality Assurance Asst. Manager

Kopran Limited; Khopoli; On-site; INR 1,000,000 - 1,800,000; Full time

Job summary

Kopran Limited in Savroli, Khopoli, Maharashtra, seeks an Assistant Manager QA to ensure quality systems compliance, review BMRs/BPRs, and support audits. The role focuses on maintaining product quality, manufacturing compliance, and audit readiness within a pharma manufacturing environment.

The candidate should have 6–10 years in QA in pharma, with relevant educational background and strong documentation and investigation skills to drive CAPAs and regulatory readiness.

Qualifications

• Knowledge of cGMP, data integrity, and pharmaceutical quality systems.
• Strong documentation and investigation skills.
• Good analytical, communication, and problem-solving abilities.
• Ability to coordinate cross-functional activities and manage priorities.
• Knowledge of regulatory audit requirements.

Responsibilities

• Review and verify Batch Manufacturing Records (BMRs) and Batch Packing Records (BPRs).
• Ensure implementation of cGMP, applicable GMP guidelines, and internal quality procedures.
• Review deviations, investigations, CAPA, change controls, and out-of-specification (OOS) / out-of-trend (OOT) investigations, as applicable.
• Monitor in-process quality activities and ensure compliance with approved procedures.
• Coordinate with Production, QC, Engineering, Warehouse, and other departments for quality-related matters.
• Review and maintain SOPs, specifications, protocols, reports, and other controlled documents.
• Support internal audits, customer audits, and regulatory inspections.
• Ensure timely closure of deviations, CAPAs, and audit observations.
• Monitor line clearance, process compliance, and documentation practices.
• Support qualification, validation, and revalidation activities.
• Participate in product complaints, market complaint investigations, and product recall activities, as applicable.
• Conduct GMP training and promote data integrity and good documentation practices.
• Ensure timely batch documentation review and release recommendations in accordance with approved procedures.
• Monitor housekeeping, hygiene, and contamination-control practices in manufacturing areas.

Skills

cGMP

Data integrity

Documentation

Analytical skills

Communication

Problem solving

Cross-functional coordination

Regulatory audits

Education

B.Pharm / M.Pharm / M.Sc.

Job description

Department: Quality Assurance (QA)
Designation: Assistant Manager QA
Industry: Pharmaceutical Manufacturing
Location: Savroli, Khopoli, Maharashtra
Reports To: QA Manager / Head – Quality Assurance

1. Job Purpose

To ensure compliance with cGMP, applicable regulatory requirements, and company quality systems. To support the QA Manager in maintaining product quality, documentation, manufacturing compliance, and audit readiness.

2. Educational Qualification

• B.Pharm / M.Pharm / M.Sc. in Chemistry or a relevant scientific discipline.

3. Experience

• 6–10 years of experience in Quality Assurance in the pharmaceutical industry.
• Experience in regulated or semi-regulated markets is preferred.

4. Key Responsibilities

1. Review and verify Batch Manufacturing Records (BMRs) and Batch Packing Records (BPRs).
2. Ensure implementation of cGMP, applicable GMP guidelines, and internal quality procedures.
3. Review deviations, investigations, CAPA, change controls, and out-of-specification (OOS) / out-of-trend (OOT) investigations, as applicable.
4. Monitor in-process quality activities and ensure compliance with approved procedures.
5. Coordinate with Production, QC, Engineering, Warehouse, and other departments for quality-related matters.
6. Review and maintain SOPs, specifications, protocols, reports, and other controlled documents.
7. Support internal audits, customer audits, and regulatory inspections.
8. Ensure timely closure of deviations, CAPAs, and audit observations.
9. Monitor line clearance, process compliance, and documentation practices.
10. Support qualification, validation, and revalidation activities.
11. Participate in product complaints, market complaint investigations, and product recall activities, as applicable.
12. Conduct GMP training and promote data integrity and good documentation practices.
13. Ensure timely batch documentation review and release recommendations in accordance with approved procedures.
14. Monitor housekeeping, hygiene, and contamination-control practices in manufacturing areas.

5. Required Skills

• Knowledge of cGMP, data integrity, and pharmaceutical quality systems.
• Strong documentation and investigation skills.
• Good analytical, communication, and problem-solving abilities.
• Ability to coordinate cross-functional activities and manage priorities.
• Knowledge of regulatory audit requirements.

6. Key Performance Indicators (KPIs)

• Timely review of batch records.
• Timely closure of deviations, CAPAs, and change controls.
• Reduction in documentation errors and recurring deviations.
• Audit readiness and compliance performance.
• Timely completion of SOP revisions and GMP training.
• Effective implementation of corrective and preventive actions.