QA/QC Manager (Factory)

Job Summary:
The Manager of Quality Control (QC) & Quality Assurance (QA) leads the factory’s quality function for medical devices and disposables (bandages, masks, medical tapes, and related products). This role ensures full compliance with Drug Regulatory Authority of Pakistan (DRAP) Medical Device Rules 2017, Good Manufacturing Practices for Medical Devices (GDPMD), and ISO 13485 Quality Management Systems. The position oversees quality testing, assurance systems, audits, regulatory compliance, and continuous improvement of product quality and safety.

Key Responsibilities

1. Regulatory & Compliance

Lead all quality and regulatory activities to ensure full compliance with DRAP Medical Device Rules 2017 and ISO 13485. You will be responsible for maintaining all necessary DRAP certifications, licenses, and product registrations. This role involves preparing for and managing documentation for DRAP audits, GMP/GDPMD inspections, and ISO audits, while acting as the primary liaison with regulatory bodies like DRAP and the Ministry of Health (MoH).

2. Quality Assurance (QA)

Oversee the entire quality assurance framework. You will develop and implement SOPs for all quality and production processes, manage all validation activities for equipment and cleanrooms, and ensure that all raw materials and finished products meet quality standards. This role requires you to lead Corrective and Preventive Actions (CAPA) for all non-conformities and manage the Document and Change Control systems.

3. Quality Control (QC)

Manage all laboratory and in-process QC testing for raw materials and finished goods. You will be responsible for monitoring and reporting on quality issues, ensuring prompt corrective action. This includes validating and maintaining testing methods, ensuring all lab instruments are properly calibrated, and approving Certificates of Analysis (CoA) for product release.

4. Risk Management & Safety

Implement a risk-based quality management system in line with ISO 14971 to ensure product safety. You will also conduct audits to maintain a hygienic and contamination-free production environment and work with the Operations Manager to achieve a Zero Total Recordable Incident Rate (TRIR).

5. Audits & Inspections

Lead internal quality audits and coordinate management reviews to ensure continuous improvement of the Quality Management System (QMS). You will also be the lead for preparing the company for DRAP and ISO surveillance audits.

6. Team Leadership & Training

Lead and mentor the QC/QA team, building their technical and compliance skills. You will conduct regular training on key quality standards like GDPMD, GMP, and ISO 13485 to foster a strong culture of quality and accountability across the organization.

7. KPI Monitoring & Reporting

Track and report on a set of key performance indicators (KPIs) to senior management and regulatory bodies. These include CAPA closure rates, material rejection rates (targeting ≤1%), product release timelines, and quality issue trends.

Education & Experience Requirements

• Education: A Bachelor’s or Master’s degree in Pharmacy, Microbiology, Biomedical Engineering, or a related field.
• Experience: A minimum of 8-12 years of experience in QC/QA within the medical device or pharmaceutical industry, with at least 3 years in a leadership role.
• Knowledge: In-depth knowledge of DRAP Medical Device Rules 2017, GDPMD, ISO 13485, and ISO 14971.

Key Skills & Competencies

Expertise in Quality Management Systems (QMS), validation, and compliance.

• Strong leadership in internal and external audit handling.
• Proficiency in CAPA, deviation handling, and root cause analysis.
• Excellent documentation, reporting, and regulatory communication skills.
• Strong analytical and problem-solving abilities.

Job Type: Full-time

Pay: Rs125,000.00 - Rs175,000.00 per month

Work Location: In person