Quality and Compliance Auditor

Quallent is actively recruiting for an Auditor to support our Quality and Compliance team.

The Person | A highly motivated professional who has a strong background in pharmacy and manufacturing, with extensive knowledge of Good Manufacturing Practice regulations and quality systems. You should possess strong analytical and problem-solving skills with advanced organizational, project management, and process management skills.

As an Auditor you will:

Perform external supplier audits of contracted facilities, including manufacturing plants, production areas, quality control labs, and support functions, to assess compliance with GMP regulations and industry standards.

Prepare comprehensive audit reports documenting findings, observations, and recommendations for corrective actions, ensuring timely follow-up on implementation.

Review documentation, records, and procedures related to manufacturing processes, equipment qualification, cleaning validation, and product testing to verify adherence to GMP requirements.

Communicate with manufacturing personnel, quality assurance, regulatory affairs, and other staff at Contract Manufacturing Organization (CMO) sites to facilitate audits and promote compliance awareness.

Evaluate the effectiveness of supplier Quality Management Systems (QMS), including document control, change control, deviation management, and Corrective and Preventative Action (CAPA) processes.

Identify non-compliance issues and areas for improvement during audits, collaborating with Quallent’s Supplier Quality Compliance team to develop corrective action plans.

Stay informed about changes to GMP regulations, FDA guidelines, and industry best practices to guide Quallent’s team.

Collaborate with cross-functional teams to train and mentor the relevant Quallent staff to serve as a subject matter expert on GMP and compliance requirements.

Help build and maintain a Quality Oversight model, to ensure regulatory compliance, identify gaps, assess their severity, and propose mitigation strategies.

Participate in strategy alignment sessions with leadership to ensure compliance initiatives are effectively executed.

Education & Experience | Bachelor’s Degree in Pharmacy, Chemistry, Biology or related field is preferred, with 2-5 years of experience in a similar role or related field. The candidate should also be proficient in MS Suite, Outlook, and Adobe Reader. Experience with various QMS (e.g. Trackwise) and ECTD systems and programs would be advantageous.

Quallent offers a highly competitive benefits package.