Supplier Quality and Regulatory Compliance – Auditor

Supplier Quality and Regulatory Compliance – Auditor

Quallent Pharmaceuticals is seeking a motivated professional who is adaptable and flexible, possessing strong analytical and problem-solving skills.
The ideal candidate will have a strong background in pharmacy and manufacturing, with extensive knowledge of Good Manufacturing Practice (GMP) regulations and quality systems.

Duties and Responsibilities

• 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
• 2-5 years of experience in a similar role or related field.
• Proficiency in MS Suite, Outlook, and Adobe Reader.
• Experience with various QMS (e.g. Trackwise) and ECTD systems and programs would be advantageous.

Salary Range: USD$85,000 – USD$100,000 per annum. Quallent also offers a highly competitive benefits package.

Applications can be submitted to hr@quallenthealth.com or through our
careers page at https://quallenthealth.bamboohr.com/careers/34
Application Deadline: April 4, 2025