- Develop and implement quality assurance strategies, policies, and procedures to maintain compliance with regulatory requirements (e.g., FDA, EMA, etc.).
- Lead internal and external audits to assess compliance with quality standards and identify areas for improvement.
- Provide guidance and support to cross-functional teams to ensure adherence to quality processes throughout the product lifecycle.
- Oversee the execution of quality control activities, including raw material testing, in-process monitoring, and finished product testing.
- Analyze quality control data to identify trends, deviations, and areas for process optimization.
- Collaborate with manufacturing and engineering teams to address quality issues and implement corrective and preventive actions (CAPAs).
- Drive continuous improvement initiatives to enhance manufacturing processes, reduce defects, and increase operational efficiency.
- Implement statistical process control (SPC) methods and other quality improvement tools to monitor and optimize process performance.
- Lead root cause analysis investigations for quality incidents and implement corrective actions to prevent recurrence.
- Stay abreast of regulatory requirements and industry standards related to pharmaceutical manufacturing.
- Interpret regulations and guidelines to ensure that manufacturing processes, documentation, and systems meet compliance requirements.
- Support regulatory submissions and inspections by providing documentation and participating in audits as needed.
- Provide training and mentorship to junior quality assurance staff to develop their skills and expertise.
- Conduct training sessions on quality principles, regulatory requirements, and best practices to enhance team capabilities.
- Bachelor's degree in engineering, pharmaceutical sciences, or a related field. Master's degree preferred.
- Minimum of 6 years of experience in quality engineering or quality assurance within the pharmaceutical industry.
- In-depth knowledge of pharmaceutical manufacturing processes, quality systems, and regulatory requirements (e.g., cGMP, ICH guidelines, etc.).
- Strong analytical skills with the ability to interpret complex data and identify trends.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively across functional teams.
- Certification in quality management (e.g., ASQ Certified Quality Engineer) is a plus.
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Senior Quality Engineer - Raleigh, United States - Connect Life Science
Description
Job Title: Senior Quality Engineer
Location: Raleigh, North Carolina
Salary: $105,000 - $110,000
Company Description: Our client are a leading pharmaceutical manufacturing company dedicated to producing high-quality medications that improve patient outcomes worldwide. With a commitment to innovation, safety, and efficacy, we strive to maintain the highest standards in every aspect of our operations.
Position Overview: As a Senior Quality Engineer, you will play a key role in ensuring that pharmaceutical manufacturing processes adhere to regulatory standards and meet quality expectations. You will lead quality assurance efforts, drive continuous improvement initiatives, and provide technical expertise to support the production of safe and effective medications.
Key Responsibilities:
Quality Assurance Leadership:
Quality Control Oversight:
Continuous Improvement:
Regulatory Compliance:
Training and Development:
Qualifications:
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