Quality Manager
Reporting to the Director of Quality, ensure all pharmaceutical products manufactured or distributed by the company comply with global and local regulatory requirements, company standards, and customer expectations.
Key Responsibilities:
* Develop, implement, and maintain the Quality Management System (QMS) in compliance with GMP, regulatory requirements, and company policies.
* Oversee the management of SOPs, Work Instructions, and other quality-related documentation.
Regulatory Compliance:
* Ensure that all products and processes comply with relevant regulations and guidelines (e.g., FDA, EMA, MHRA).
* Stay updated with changes in regulatory requirements and ensure timely implementation of necessary changes.
Audits and Inspections:
* Lead internal audits and participate in external audits and regulatory inspections.
* Prepare audit reports, manage corrective and preventive actions (CAPAs), and follow up on audit findings.
Training and Development:
* Develop and execute training programs for staff on quality-related topics to ensure compliance with regulatory requirements and company standards.
* Monitor the effectiveness of training programs and maintain training records.
Quality Control:
* Oversee the quality control processes, including raw material testing, in-process monitoring, and final product testing.
* Ensure that all quality control activities are documented and carried out in accordance with established procedures.
Deviation and Change Control Management:
* Manage and investigate deviations, non-conformances, and product complaints.
* Oversee the change control process to ensure proper evaluation, approval, and implementation of changes in procedures, equipment, or processes.
Product Release:
* Collaborate with the Qualified Person (QP) to ensure that batch documentation is reviewed, and products are released in compliance with regulatory requirements and company standards.
Continuous Improvement:
* Promote a culture of continuous improvement by identifying areas for improvement and implementing effective solutions.
* Use quality metrics and data analysis to drive process improvements and enhance product quality.
Supplier Quality Management:
* Evaluate and qualify suppliers and contractors to ensure they meet the company's quality standards.
* Manage supplier audits and assessments to maintain a high level of quality throughout the supply chain.
Requirements:
* Bachelor's degree or higher in Pharmacy, Chemistry, Biology, or a related field.
* A minimum of 5 years of experience in quality management within the pharmaceutical industry.
* In-depth knowledge of GMP, FDA, EMA, and other relevant regulatory requirements.
* Experience with QMS implementation and management.
Skills and Competencies:
* Strong leadership and team management skills.
* Excellent communication and interpersonal skills.
* Attention to detail and strong analytical skills.
* Ability to handle multiple tasks and prioritize effectively.
* Proficiency in risk management and problem-solving.
* Competency in using quality management software and tools.