Company Overview: Our pharmaceutical company is dedicated to delivering high-quality, innovative healthcare solutions to improve the lives of patients worldwide. We adhere to stringent quality standards and regulatory requirements to ensure the safety, efficacy, and compliance of our products.
Position Overview: As the Quality Manager, you will play a crucial role in maintaining and enhancing our quality management system to meet regulatory requirements and industry best practices. You will lead a team of quality professionals to ensure that our pharmaceutical products meet the highest standards of quality, safety, and efficacy.
Key Responsibilities:
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Quality Management System Oversight:
- Develop, implement, and maintain the company's quality management system (QMS) in accordance with applicable regulations, standards, and guidelines (e.g., FDA, EMA, ICH).
- Monitor and continuously improve the effectiveness of the QMS through audits, reviews, and process enhancements.
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Regulatory Compliance:
- Stay abreast of changes in regulations and guidelines relevant to the pharmaceutical industry and ensure the company's compliance with all applicable requirements.
- Prepare for and participate in regulatory inspections and audits, addressing any findings and implementing corrective and preventive actions as necessary.
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Quality Assurance:
- Establish and enforce quality assurance processes and procedures throughout the product lifecycle, from development through manufacturing and distribution.
- Conduct product quality reviews, investigations, and risk assessments to identify and mitigate quality issues and deviations.
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Supplier and Vendor Management:
- Collaborate with procurement and supply chain teams to ensure the qualification and oversight of suppliers and vendors, including contract manufacturing organizations (CMOs) and raw material suppliers.
- Evaluate supplier performance and manage relationships to ensure the consistent supply of high-quality materials and services.
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Quality Training and Documentation:
- Develop and deliver training programs to ensure that all employees understand and comply with quality standards, procedures, and regulations.
- Maintain accurate and up-to-date documentation, including SOPs, batch records, and quality records, in accordance with regulatory requirements.
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Quality Metrics and Reporting:
- Define and track key quality metrics and performance indicators to monitor the health of the QMS and identify opportunities for improvement.
- Prepare regular reports and presentations for management, highlighting quality trends, compliance status, and areas for corrective action.
