Quality Systems Engineer
vor 1 Monat
I am partnered with one of the leading pharmaceutical company dedicated to improving the health and well-being of people around the world. We are committed to delivering high-quality, innovative, and life-saving pharmaceutical products. Our mission is to make a positive impact on global healthcare through our dedication to excellence, research, and development.
Job Description: We are seeking a highly motivated and detail-oriented Quality Systems Engineer to join our dynamic team. The Quality Systems Engineer will play a critical role in ensuring that our pharmaceutical manufacturing processes and systems are compliant with regulatory standards and consistently deliver safe and effective products to our customers.
Key Responsibilities:
- Quality Systems Management:
- Develop, implement, and maintain quality management systems in compliance with industry standards, including but not limited to FDA, EMA, and ISO.
- Documentation Control:
- Manage and oversee the document control process, including document creation, review, approval, and archiving.
- Ensure all documents related to manufacturing, validation, and quality are accurate, up-to-date, and accessible to relevant personnel.
- Change Control:
- Facilitate change control processes to assess and document the impact of proposed changes on quality systems, processes, and products.
- Collaborate with cross-functional teams to implement approved changes efficiently.
- Audit and Inspection Support:
- Prepare for and support regulatory audits and inspections, ensuring all quality systems are audit-ready at all times.
- Address audit findings and implement corrective and preventive actions.
- Continuous Improvement:
- Identify areas for process improvement within the quality systems and drive initiatives to enhance efficiency and effectiveness.
- Monitor key performance indicators (KPIs) to track the performance of quality systems and recommend improvements as necessary.
- Training and Development:
- Provide training and guidance to personnel on quality system processes and procedures.
- Foster a culture of quality and compliance throughout the organization.
Qualifications:
- Minimum of 1 years of experience in quality systems management within the pharmaceutical industry.
- Strong knowledge of FDA, EMA, and ISO quality system regulations and guidelines.
- Experience with document control, change control, and audit processes.
- Excellent problem-solving and analytical skills.
- Strong communication and interpersonal skills.
- Detail-oriented with a commitment to quality and compliance.
Benefits
Benefits:
- Competitive salary and bonus structure
- Comprehensive healthcare and wellness benefits
- Retirement savings plan
- Career development and training opportunities
- A collaborative and innovative work environment
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