GMP Compliance Auditor

4 weeks ago

Harrogate, North Yorkshire, United Kingdom HAR Labcorp Early Development Laboratories Limited Full time

Are you experienced in GMP operations or biologics within the industry?

Do you have a strong commitment to quality assurance and seek a role within a supportive and stable environment?

Are you interested in a position that offers a clear path for career advancement?

If this resonates with you, continue reading.

Recognized as one of the leading employers globally and celebrated for our commitment to excellence, at Labcorp, we aim to enhance people's lives by delivering essential products to the market. As a GMP Quality Assurance Auditor at Labcorp, you will play a vital role in achieving this mission.

The GMP Quality Assurance Auditor is tasked with aiding the local execution and functioning of the GMP Quality Management System. This role is pivotal in ensuring that the site adheres to GMP compliance through participation in audits, data assessments, investigations, validation initiatives, and the provision of GMP-related training.

Key Responsibilities Include:

Engaging in quality issue resolutions and initiatives aimed at enhancing quality and efficiency, assessing impacts, investigating root causes, and planning and executing proposed actions. Monitoring, compiling, and reporting on relevant quality metrics and data trends associated with the local performance of the quality management system for inclusion in the Management Review Process; evaluating and reporting post-market surveillance data in line with regulatory requirements. Assisting in the delivery of fundamental regulatory-based training. Supporting the internal audit program by participating in audits of systems, processes, and facilities. Overseeing study-specific activities: a. Pharmaceutical GMP Studies: Conducting regulatory reviews of study-related documentation (e.g., methods, protocols, reports, certificates of analysis) prior to approval by senior GMP QA personnel. b. CDx Studies: Developing quality plans that facilitate the advancement of Medical Device and/or IVD products. Aiding validation and verification activities, including but not limited to protocol development and execution, as well as deviation/non-conformance resolution; reviewing key validation deliverables. Evaluating metrology methods and specifications for accuracy, relevance, and compliance with applicable quality standards. Maintaining processes to support document and configuration control requirements. Reviewing and approving site-based controlled documents (SOPs, Policies, etc.) to ensure compliance with relevant regulations, Labcorp document management procedures, and other pertinent quality standards. Ensuring adherence to Regulatory Compliance and Quality Assurance (RC&QA) responsibilities as outlined in applicable controlled documents.

What Labcorp Provides:

Competitive salary and benefits package, including health coverage and a contributory pension. Significant interaction with internal and external stakeholders, including clients and regulatory bodies. Opportunities for professional development and growth while contributing to the well-being of individuals. A culture of CARE with access to well-being programs and various employee resource groups. Flexible and hybrid work arrangements following the completion of training. Comprehensive relocation package (subject to criteria).

Educational Requirements:

A minimum of a Bachelor's Degree in a Chemistry or Biology-related field. A postgraduate degree (MSc or equivalent) in a science or management-related discipline is preferred.

Skills and Experience:

Proven experience in GMP auditing or laboratory work within a drug development or pharmaceutical context. In-depth knowledge of Good Manufacturing Practice Regulations. General awareness of industry quality systems and standards, such as ICHQ10. Strong communication, decision-making, negotiation, and problem-solving skills. Experience in process improvement initiatives. Customer service-oriented, with the ability to effectively engage with clients. Capability to work with minimal supervision. Excellent verbal and written communication skills.

Labcorp is committed to being an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp emphasizes diversity and inclusion within the workforce and does not tolerate any form of harassment or discrimination. Employment decisions are made based on business needs and individual qualifications, without discrimination based on race, religion, color, national origin, gender (including pregnancy or other medical conditions), family or parental status, marital status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.

We encourage all qualified individuals to apply.

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