Posted May 20, 2026 217 views
Agay Barho is looking for an experienced Quality Assurance Manager to lead quality assurance activities within our pharmaceutical manufacturing environment. The successful candidate will oversee Batch Manufacturing Records to ensure accuracy and compliance, develop and maintain standard operating procedures in line with regulatory standards, and lead factory inspections conducted by pharmaceutical customer inspection teams. This position requires a detail-oriented professional with a strong understanding of industry regulations, quality systems, and manufacturing practices. The role demands excellent communication skills, the ability to work collaboratively across functions, and a commitment to upholding high-quality standards throughout the production process.
The Quality Assurance Manager will work closely with various departments to monitor compliance with quality systems and regulatory requirements. While this position does not include managing a team, the role requires strong leadership capabilities to implement corrective and preventive actions and to guide teams during audits and inspections. A Bachelors degree in Pharmacy and at least six years of relevant experience within the pharmaceutical quality department are essential to succeed in this role. The candidate must be capable of working under pressure while consistently ensuring adherence to all quality assurance processes and regulations.
Responsibilities
- Oversee the preparation, review, and approval of Batch Manufacturing Records (BMRs) to ensure they meet established standards and regulatory requirements.
- Implement and monitor corrective and preventive actions derived from BMR findings to maintain high-quality manufacturing outputs.
- Develop, write, and update Standard Operating Procedures (SOPs) related to the manufacturing of empty hard gelatin capsules, ensuring alignment with current industry standards and regulatory requirements.
- Monitor ongoing compliance with regulatory frameworks, company policies, and quality assurance standards within the manufacturing environment.
- Collaborate with cross-functional teams including production, quality control, and regulatory affairs to identify, address, and resolve quality and compliance issues.
- Lead the coordination and preparation for factory inspections conducted by pharmaceutical customer inspection teams, ensuring the facility meets customer and regulatory expectations.
- Coordinate closely with relevant departments to address any non-conformities or concerns raised during inspections and to implement effective corrective measures.
- Maintain comprehensive documentation and records related to quality assurance activities, including inspection reports, audit findings, and quality metrics.
- Stay updated on changes in industry regulations, guidelines, and best practices to ensure the organization consistently adheres to applicable quality standards.
- Communicate quality procedures, policies, and updates effectively to relevant stakeholders to promote awareness and compliance across the organization.
- Assist in training and mentoring personnel on quality assurance processes, emphasizing regulatory compliance and quality improvement.
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