Quality Assurance Director
5 days ago
We are seeking a highly skilled Quality Assurance Director to lead and manage the Quality Assurance function in our Analytical Testing Laboratory. The ideal candidate will have extensive experience in handling critical audits, including USFDA, CAPA, GLP, WHO, NABL, and internal audits.
About QIMAOur company is committed to delivering high-quality testing services that meet regulatory requirements and industry standards. We strive to maintain a culture of continuous quality improvement across our laboratory, encouraging proactive problem-solving and adherence to quality systems.
Job DescriptionThe Quality Assurance Director will be responsible for:
- Developing, implementing, and maintaining the Quality Management System (QMS) to comply with regulatory requirements and industry standards;
- Overseeing the preparation and management of documentation, including standard operating procedures (SOPs), batch records, test methods, and analytical reports;
- Implementing risk management strategies to identify, assess, and mitigate quality-related risks within the testing laboratory;
- L领导 and managing USFDA, WHO, NABL, GLP, and other regulatory audits;
- Ensuring timely and effective resolution of audit findings by developing and executing Corrective and Preventive Actions (CAPA);
- Serving as the primary point of contact during external regulatory audits, inspections, and accreditation assessments;
The successful candidate will possess:
- A Bachelor's or Master's degree in Chemistry, Biology, Pharmaceutical Sciences, or a related field;
- Minimum 15 years of experience in a Quality Management role within a pharmaceutical testing laboratory;
- Proven experience in managing and handling audits, including USFDA, WHO, NABL, GLP, CAPA, and internal audits;
- In-depth knowledge of regulatory standards and guidelines, including GMP, GLP, FDA, EMA, and ICH;
- Strong leadership skills with the ability to mentor and lead teams to achieve compliance and quality objectives;
- Excellent communication and interpersonal skills to interact effectively with regulatory authorities, senior management, and cross-functional teams;
- Detail-oriented with strong problem-solving skills and the ability to assess and mitigate risks effectively.
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