Quality Assurance Consultant

Quality Assurance Consultant – Drive Excellence in Regulatory Compliance and Quality Standards

Are you a detail-oriented professional with a passion for ensuring the highest standards of quality and compliance in the pharmaceutical or healthcare industry? We are seeking a dynamic and experienced Quality Assurance Consultant to play a pivotal role in implementing, maintaining, and overseeing our Quality Management System (QMS) across local affiliates. This strategic position requires a proactive leader who can navigate complex regulatory landscapes, mitigate quality risks, and foster a culture of continuous improvement. If you thrive in a fast-paced environment where precision and accountability drive success, we invite you to join our team and make a meaningful impact.

In this critical role, you will serve as the cornerstone of quality assurance, ensuring that all operations align with global regulatory requirements, industry best practices, and company policies. Your expertise will be instrumental in maintaining the integrity of our products, safeguarding patient safety, and upholding our reputation for excellence. This is more than a job—it’s an opportunity to shape the future of quality assurance in a dynamic and innovative organization.

Key Responsibilities

As the Quality Assurance Consultant, your responsibilities will span a broad spectrum of quality functions, demanding both technical expertise and strategic leadership. Your day-to-day duties will include:

• QMS Leadership: Implement, maintain, and oversee the Quality Management System (QMS) within local affiliates, ensuring full compliance with regulatory standards and internal policies.
• Documentation Management: Maintain and update the local Quality Manual and Site Master File, ensuring all documentation is accurate, current, and readily accessible for audits and inspections.
• Quality Risk Management: Identify, analyze, and mitigate quality risks across all affiliate operations, communicating findings clearly and escalating issues as necessary to ensure timely resolution.
• Complaint and Deviation Handling: Act as the Local Complaint Coordinator, managing the reporting, assessment, and investigation of complaints while overseeing the management of internal, external, and transport deviations to prevent recurrence.
• Change Control and CAPA: Lead change control processes, conducting QA assessments and reviews to ensure smooth implementation and closure of changes. Manage Corrective and Preventive Actions (CAPA) stemming from deviations, audits, and inspections, driving continuous improvement initiatives.
• Inspection and Audit Oversight: Coordinate and manage authority inspections and self-inspections, ensuring full preparedness and compliance with regulatory expectations.
• GxP Surveillance and Product Quality Reviews: Conduct GxP surveillance and product quality reviews (PQR) to monitor and enhance product performance and compliance.
• Training and Development: Manage training programs, including the maintenance of training matrices, delivery of annual GxP refresher training, and oversight of training assignments within the Learning Management System (LMS).
• Product Release and Distribution: Oversee local product release processes, shipment reviews, goods receipt checks, and deviation handling to ensure seamless and compliant distribution. Manage shipping lane qualifications and transport performance for secondary distribution.
• GDP Compliance: Ensure adherence to Good Distribution Practices (GDP) for warehousing and distribution operations, maintaining the highest standards of product integrity.
• Return and Recall Management: Evaluate product returns against established criteria, collaborate with distributors, and manage product recalls, including local execution, customer communication, and recall reconciliation.
• Supplier Quality Management: Identify, qualify, and approve suppliers, conduct annual compliance evaluations, and plan and execute quality audits. Approve and close CAPAs related to supplier performance.
• Repackaging and Relabeling: Manage change control processes for repackaging and relabeling activities, including protocol development, execution, QA review, and product release.

This role requires a blend of technical proficiency, analytical rigor, and strong interpersonal skills to collaborate effectively with cross-functional teams, including operations, regulatory affairs, and supply chain. Your ability to drive process improvements and maintain a proactive stance on quality will be instrumental in achieving our organizational goals.

Qualifications and Competencies

We are seeking a highly qualified professional with a proven track record in quality assurance within the pharmaceutical or healthcare industry. To excel in this role, you should possess the following:

• Education: A Bachelor’s degree in Quality Management, Life Sciences, or a related field is required.
• Experience: A minimum of five years of experience in Quality Assurance, with a strong focus on pharmaceutical or healthcare environments.
• Regulatory Expertise: In-depth knowledge of GxP regulations, including GMP, GDP, and other relevant quality standards, is essential.
• Analytical and Problem-Solving Skills: Exceptional ability to analyze complex issues, identify root causes, and develop effective solutions.
• Communication and Collaboration: Strong written and verbal communication skills, with the ability to engage effectively with stakeholders at all levels.
• Technical Proficiency: Proficiency in using Quality Management Systems (QMS) and Learning Management Systems (LMS) to streamline processes and enhance efficiency.
• Key Competencies:
• Attention to detail and unwavering accuracy in all quality-related activities.
• Strong organizational and time management skills to balance multiple priorities and deadlines.
• Effective leadership and team management abilities to mentor and guide local staff.
• A proactive and results-driven mindset, committed to continuous improvement and excellence.

If you are a detail-oriented, results-driven professional with a passion for quality assurance and a commitment to driving excellence, we encourage you to apply and be part of our mission to set the standard for quality in the industry.