Senior Quality Auditor
This is a highly rewarding opportunity to contribute to global healthcare while ensuring compliance and quality in supplier management.
Job Summary:
We are seeking a highly motivated and experienced Senior Quality Auditor to join our client's team. As a Senior Quality Auditor, you will be responsible for mentoring and developing team members, overseeing the lifecycle management of approved vendors and suppliers, collaborating with cross-functional departments, and establishing and monitoring KPIs.
Key Responsibilities:
* Mentor and develop team members to support their professional growth.
* Oversee the lifecycle management of approved vendors and suppliers in line with industry regulations and guidelines.
* Collaborate cross-functionally with departments like Supply Chain, Regulatory, and Quality to ensure alignment of qualification activities with business needs.
* Travel nationally and internationally as part of the role's responsibilities.
* Deputize for the Senior Quality Manager - Supplier Assurance as required.
* Establish and monitor KPIs, providing evaluations and reporting on related metrics.
* Manage a risk-based audit program for vendors and suppliers used in the client's products (excluding Pharmacovigilance suppliers/partners).
* Conduct risk analysis-based outcomes on Quality audits, collaborating with QPs and management on follow-up actions.
* Ensure audits meet current EU GMP, EU GDP, or equivalent standards, as well as relevant marketing authorization (MA) requirements.
* Maintain and track CAPAs (Corrective and Preventive Actions) internally and with external suppliers.
* Keep vendor data valid and up to date in the SAP ERP system.
* Evaluate and interpret global regulations for audit activities.
* Create, revise, and review documentation related to QA audit checklists, questionnaires, and other SOPs/guidance documents as required.
Requirements:
* A degree in Chemistry, Pharmacy, Microbiology, or a related field.
* General Auditing Qualification.
* External Lead Auditing Qualification.
* At least 2 years of experience in a similar role within the pharmaceutical industry.
* Strong organizational skills with the ability to prioritize and work under pressure.