: Assistant Manager – Quality Assurance (QA)

Department: Quality Assurance

Designation: Assistant Manager – QA

Reporting To: Manager / Head – Quality Assurance

Industry: Pharmaceutical / API Manufacturing

Experience: 10–15 Years

Employment Type: Full-Time

Location: Turbhe

1. Job Purpose

To lead and oversee Quality Assurance activities and ensure effective implementation of the Quality Management System in compliance with cGMP, regulatory requirements, data integrity principles, approved procedures, and company quality standards. The role will be responsible for providing QA oversight to manufacturing operations, managing quality systems, leading investigations, supporting regulatory/customer audits, and guiding the QA team.

1. Key ResponsibilitiesA. Quality Management System

- Lead implementation and continuous improvement of the Quality Management System.
- Review, approve, and maintain SOPs, specifications, protocols, reports, and other controlled documents.
- Manage and monitor Deviation, CAPA, Change Control, OOS/OOT, Market Complaints, and Quality Risk Management activities.
- Ensure timely investigation, root-cause analysis, CAPA implementation, and effectiveness checks.
- Monitor recurring quality issues and initiate appropriate preventive actions.
- Ensure compliance with data integrity and good documentation practices.

B. Batch Documentation & QA Review
- Review and approve BMRs, BPRs, analytical records, equipment logbooks, and other GMP documentation.
- Ensure accurate, complete, and timely review of batch documentation.
- Provide QA oversight for batch manufacturing and release-related activities.
- Ensure discrepancies and documentation errors are appropriately investigated and resolved.

C. Shop-Floor QA & GMP Compliance
- Provide QA oversight of manufacturing, packing, dispensing, and storage activities.
- Conduct routine GMP inspections and shop-floor audits.
- Ensure compliance with approved SOPs, specifications, process parameters, and GMP requirements.
- Identify potential quality risks and ensure timely corrective actions.
- Work closely with Production, QC, Engineering, Warehouse, and other functions to resolve quality issues.

D. Investigations & CAPA
- Lead or review investigations related to deviations, OOS/OOT, process failures, complaints, and other quality events.
- Ensure scientifically sound root-cause analysis using appropriate investigation tools.
- Review CAPA plans and monitor implementation and effectiveness.
- Ensure timely closure of investigations and CAPAs.

E. Audits & Regulatory Inspections
- Lead/support internal audits, customer audits, regulatory inspections, and vendor audits.
- Coordinate audit preparation and ensure site inspection readiness.




- Review responses to audit observations and monitor CAPA commitments.
- Support regulatory inspection teams during inspections.
- Maintain effective systems for tracking audit observations and commitments.

F. Validation & Qualification
- Review and approve validation/qualification protocols and reports.
- Provide QA oversight for:
- Process validation
- Cleaning validation
- Equipment qualification
- Analytical method validation
- Hold-time studies
- Computerized system validation, where applicable
- Ensure validation activities comply with approved procedures and regulatory expectations.

G. Quality Risk Management
- Lead and participate in Quality Risk Assessments.
- Evaluate risks associated with processes, equipment, materials, systems, and changes.
- Ensure appropriate risk mitigation measures are implemented.
- Promote risk-based decision-making across the organization.

H. Training & Compliance
- Identify GMP and QA training requirements for employees.
- Conduct training on GMP, SOPs, data integrity, documentation practices, investigations, and quality systems.
- Monitor training effectiveness and compliance.
- Promote a strong quality culture throughout the organization.

I. Team Leadership
- Lead, supervise, and mentor QA officers, executives, and other QA personnel.
- Allocate responsibilities and monitor team performance.
- Develop team competencies through coaching and training.
- Conduct performance reviews and provide feedback.
- Ensure adequate QA manpower and effective execution of departmental activities.

J. Cross-Functional Coordination
- Coordinate with Production, QC, R&D;, Engineering, Regulatory Affairs, Warehouse, EHS, and other departments.
- Provide QA guidance for process improvements and operational changes.
- Escalate critical quality and compliance issues to senior management.

1. Key Performance Indicators (KPIs)

- Timely closure of deviations, CAPA, and change controls.
- Reduction in recurring deviations and quality incidents.
- Batch documentation review within defined timelines.
- Audit and regulatory inspection readiness.
- Successful closure of audit observations.
- Compliance with GMP and data integrity requirements.
- Timely completion of QA investigations.
- Training compliance and effectiveness.
- Effective implementation and continuous improvement of QMS.

1. Educational Qualification

Essential:

- B.Pharm / M.Pharm / M.Sc. / B.Sc. in Chemistry, Life Sciences,



or related discipline.

Preferred:

- M.Pharm / relevant postgraduate qualification.
- Certification or training in GMP, Quality Management, regulatory compliance, auditing, or related areas.

1. Experience

- 10–15 years of relevant experience in Quality Assurance, preferably within API / pharmaceutical manufacturing.
- Strong experience in QMS, GMP compliance, investigations, CAPA, change control, batch documentation, audits, and regulatory inspection management.
- Experience in managing and developing QA teams.
- Exposure to domestic and/or international regulatory requirements will be an advantage.

1. Technical Skills

- Strong knowledge of cGMP and pharmaceutical quality systems.
- Good understanding of API manufacturing processes.
- Strong knowledge of:
- Deviations
- CAPA
- Change Control
- OOS/OOT
- Quality Risk Management
- Audit Management
- Data Integrity
- Validation & Qualification
- Document Control
- Batch Record Review
- Complaint Management
- Knowledge of regulatory expectations and inspection requirements.
- Good working knowledge of MS Office and electronic QMS.

1. Behavioral & Leadership Competencies

- Strong leadership and people-management skills.
- Excellent analytical and problem-solving ability.
- Strong decision-making skills.
- Excellent written and verbal communication.
- High attention to detail.
- Ability to work under pressure and meet deadlines.
- Strong cross-functional coordination.
- Quality-oriented and compliance-focused approach.
- Ability to independently handle critical quality issues.

1. Internal & External Interfaces

Internal: QA | QC | Production | R&D; | Engineering | Regulatory Affairs | Warehouse | EHS | Procurement | HR

External:

Regulatory Authorities | Customers | Auditors | Vendors | Consultants | Contract Service Providers

1. Authority & Accountability

- Review and approve QA documents within assigned authority.
- Lead or participate in quality investigations and risk assessments.
- Recommend corrective and preventive actions.
- Escalate critical quality and GMP compliance issues to senior management.
- Provide QA clearance/approval in accordance with established procedures.
- Ensure effective implementation of the Quality Management System within the assigned area.

1. Overall Responsibility

The Assistant Manager – QA will be responsible for ensuring robust QA oversight of manufacturing and quality operations, maintaining GMP compliance, leading quality investigations and QMS activities, supporting audits and regulatory inspections, and developing the QA team to maintain consistent product quality and regulatory Pay: ₹800,000.00 - ₹1,500,000.00 per year

Advantages

- Provident Fund

Work Location: In person

📌 Assistant Manager QA (Navi Mumbai)
🏢 Great Pacific Export
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