Job Purpose
The Quality Assurance Manager is responsible for establishing, implementing, maintaining, and continuously improving the company’s Quality Management System (QMS) to ensure that all pharmaceutical products are consistently manufactured, packaged, stored, and released in accordance with GMP requirements, approved specifications, company SOPs, and applicable regulatory requirements.
The position ensures that quality is built into every stage of the operation and works closely with Production, Quality Control, Warehouse, Engineering, Procurement, and Regulatory Affairs to prevent quality failures and ensure continuous compliance.
Key Responsibilities
A. Quality Management System
- Develop, implement, maintain, and improve the company’s Quality Management System.
- Ensure implementation and compliance with approved SOPs, policies, specifications, and quality procedures.
- Review and approve quality-related documents.
- Ensure proper document control and record management.
- Establish and monitor quality objectives and KPIs.
B. GMP Compliance
- Ensure compliance with Good Manufacturing Practices (GMP) and applicable pharmaceutical regulations.
- Monitor GMP compliance throughout production, packaging, storage, and other relevant operations.
- Conduct routine GMP inspections and identify areas requiring corrective action.
- Promote a strong quality culture throughout the organization.
C. Batch Documentation and Release
- Review Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), and other relevant documentation.
- Ensure deviations, investigations, and corrective actions are completed before batch disposition.
- Coordinate with QC and other relevant departments regarding product quality issues.
- Ensure that products are not released unless all required quality requirements have been fulfilled.
D. Deviation, CAPA and Change Control
- Manage the deviation reporting and investigation process.
- Ensure root-cause analysis is properly conducted.
- Review, approve, and monitor CAPA (Corrective and Preventive Action) plans.
- Manage and approve change-control procedures.
- Follow up on effectiveness of corrective and preventive actions.
E. Validation and Qualification
- Review and approve validation and qualification protocols and reports.
- Ensure appropriate validation of:
- Manufacturing processes
- Cleaning processes
- Equipment
- Utilities
- Computerized systems, where applicable
- Ensure validation activities are performed according to approved procedures.
F. Internal Audit and Inspection
- Develop and implement an annual internal audit plan.
- Conduct or supervise internal GMP audits.
- Document audit findings and ensure timely corrective actions.
- Follow up on CAPA implementation and effectiveness.
- Support regulatory inspections and external audits.
G. Supplier and Material Quality
- Participate in qualification and evaluation of suppliers.
- Review quality-related aspects of suppliers and contractors.
- Ensure incoming raw materials and packaging materials meet approved requirements.
- Monitor supplier performance and quality issues.
H. Training
- Develop and coordinate GMP and quality-related training programs.
- Ensure employees are trained on relevant SOPs before performing assigned activities.
- Maintain training records and evaluate training effectiveness.
I. Complaints, Returns and Product Quality
- Manage investigation of customer complaints related to product quality.
- Coordinate investigation of returned products.
- Identify recurring quality problems and initiate CAPA where necessary.
- Support product recall procedures when required.
J. Quality Risk Management
- Implement quality risk-management principles throughout the organization.
- Identify potential risks affecting product quality and patient safety.
- Ensure appropriate controls are established for identified risks.
K. Quality Reporting
Prepare regular reports for senior management covering:
- Quality KPIs
- Deviations
- CAPA status
- Audit findings
- Complaints
- Batch release status
- Change controls
- Validation activities
- Training status
- Major quality risks and recommendations
