QUALITY ASSURANCE MANAGER

Human Capital HR Solutions is seeking a Quality Assurance Manager for a leading pharmaceutical company based in Karachi. This full-time, on-site role requires a dedicated professional to oversee and enhance the quality management systems within the organization, ensuring strict adherence to regulatory standards and continuous improvement in quality processes.

Key Responsibilities:
- Develop, implement, and maintain comprehensive Quality Management Systems (QMS) aligned with industry standards.
- Ensure compliance with pharmaceutical regulations and Good Manufacturing Practices (GMP).
- Manage Standard Operating Procedures (SOPs), deviations, Corrective and Preventive Actions (CAPA), change control processes, risk assessments, and all related documentation.
- Conduct internal audits and facilitate external and regulatory inspections to maintain compliance.
- Review and approve batch manufacturing records and other quality-related documentation to guarantee accuracy and completeness.
- Investigate quality incidents, deviations, and customer complaints thoroughly to identify root causes and implement corrective measures.
- Collaborate closely with Quality Control (QC), Production, and Regulatory Affairs teams to align quality objectives across departments.
- Monitor key quality performance indicators and lead initiatives aimed at continuous quality improvement.

Required Qualifications:
- Pharm-D or a relevant Pharmacy degree is mandatory.
- Proven experience in Quality Assurance within the pharmaceutical industry.
- Strong knowledge of GMP, pharmaceutical quality systems, and regulatory compliance requirements.
- Hands-on experience with audits, CAPA, deviation management, and documentation control.
- Excellent leadership abilities combined with strong analytical, problem-solving, and communication skills.

This position offers an excellent opportunity for a quality-focused professional to contribute to a reputable pharmaceutical company’s success by ensuring the highest standards of product quality and regulatory compliance. The role demands a proactive approach and the ability to work collaboratively within a multidisciplinary team.

Interested candidates who meet the above criteria are encouraged to apply for this opportunity based in Karachi. The work location is strictly on-site, emphasizing direct engagement with operational teams and regulatory bodies.