Quality Manager
4 weeks ago
**Role purpose**
Responsible for implementing, developing and maintaining quality management policies, processes and procedures and support QMS implementation and improvement. The position will focus on maintaining a robust Quality Management System (QMS) for retail and wholesale operations.
**Key Accountabilities**
**Quality Assurance (QA)**:
- Develop, implement, and maintain a robust Quality Management System (QMS) for retail and wholesale operations.
- Conduct regular audits of retail and warehouse facilities to ensure compliance with Good Distribution Practices (GDP), Good Pharmacy Practices (GPP), and regulatory standards.
- Ensure product storage, handling, and transportation conditions meet quality requirements (e.g., temperature control, humidity, inventory management).
**Regulatory Compliance**:
- Stay updated on local and international pharmaceutical regulations (e.g.,NHRA, FDA, EMA, WHO,GTDP, GSP/GDP guidelines).
- Serve as the primary liaison with regulatory authorities during inspections and audits.
- Prepare and submit compliance documentation as required by local health authorities.
**Supplier and Vendor Quality Management**:
- Collaborate with Pharmaceutical companies to address quality-related issues and ensure corrective actions are implemented.
- Understand the quality and operational requirements of pharmaceutical companies to ensure that the contractual requirements are met.
**Training & Awareness**:
- Develop and deliver quality-related training programs to staff in retail and wholesale operations.
- Promote a culture of quality awareness throughout the organization.
- Provide training to employees on QMS requirements and quality standards.
**Risk Management**:
- Identify, assess, and mitigate quality risks in the supply chain and distribution process.
- Investigate and resolve quality complaints, non-conformances, and deviations, ensuring corrective and preventive actions (CAPAs) are implemented.
**Documentation and Reporting**:
- Maintain accurate records of quality audits, inspections, complaints, and corrective actions.
- Prepare periodic quality performance reports for senior management.
**Continuous Improvement**:
- Analyze quality metrics to identify trends and areas for improvement.
- Recommend and implement strategies to optimize quality processes and enhance operational efficiency.
**Quality Management Systems**
- Develop, implement, and maintain Quality Management System (QMS) in compliance with the ISO standards.
- Develop and maintain quality risk management policies, processes and procedures to support QMS implementation and improvement.
- Facilitate external certification assessment for ISO 9001 by organizing and overseeing the certification process.
- Drive continuous improvement efforts and monitor and analyze quality performance metrics to identify trends and areas for improvement.
- Collaborate with cross-functional teams to implement quality improvement initiatives and resolve quality issues.
**Role-specific experience and skills**
- Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, or a related field.
- Advanced degree (e.g., MBA, MSc) or professional certifications in Quality Management (e.g., Six Sigma, ISO 9001) are a plus.
- Proficient in ISO standards
- 3-5 years of experience operating and administering QMS in the pharmaceutical industry.
- Experience in dealing with quality audits in relation to MNCs.
- Strong knowledge of pharmaceutical regulations, including GDP, GMP standards.
- Excellent problem-solving, analytical, and decision-making abilities.
- Effective communication and leadership skills to influence cross-functional teams.
- Proficiency in quality management software and tools.
- Attention to detail and ability to work in a fast-paced environment.
- Strong problem-solving abilities and skilled in conducting audits, analyzing findings, and implementing corrective actions and effective solutions.
- Excellent communication skills for conveying quality requirements and policies.
- Analytical skills to assess quality performance using data and metrics.
- Experienced in project management for quality improvement initiatives is an advantage.
- Meticulous attention to detail for ensuring compliance with standards.
- Collaborative mindset, able to work effectively with teams and stakeholders to achieve quality objectives.
- Teamwork and collaboration skills
**Job Types**: Full-time, Permanent
**Experience**:
- operating & administering QMS in pharmaceutical industry: 3 years (required)
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