About the client:PSS has been mandated to hire a
Lead Quality Auditor for one of the leading pharmaceutical organizations.
Job Purpose
Purpose of the role:
The Lead Auditor will work collaboratively with the Operations team, Scientific Affairs team, and stakeholders to define and deliver quality and compliance plans and objectives. This is to ensure the products supplied to our customers meet the relevant regulatory standards, contractual obligations, and our internal quality standards.
The Lead Auditor manages and delivers the organization's Supplier Audit program to ensure the company's quality and compliance standards are communicated and maintained. Responsibilities include managing the audit program and auditing staff; performing routine GMP, for-cause, and due-diligence audits of current and potential suppliers/manufacturers; delivering audit reports; ensuring CAPAs are addressed and closed promptly; and maintaining the audit system and metrics.
The Lead Auditor will ensure that all activities are completed with the highest level of care and accuracy, and promptly to maintain continuity of supply. In addition, the role will focus on continuously improving our compliance stature by ensuring our suppliers meet regulatory requirements and the organization's quality expectations.
Key Responsibilities
- Manage the Supplier Audit program including audit scheduling, reporting, follow-up on CAPAs, and generation of associated metrics
- Collaborate with internal stakeholders to understand the business needs and context driving the Audit and Qualification program
- Schedule and perform supplier audits as Lead Auditor
- Perform GMP audits to assess and assure existing supplier compliance profiles.
- Perform due diligence audits to assess the quality and compliance risk profile for new suppliers and contract manufacturers.
- Perform for-cause audits to investigate and assess the risk posed by suppliers that have reported significant, repetitive deviations or quality issues, or suppliers that have had adverse regulatory authority findings made against them.
- Deliver reports of appropriate accuracy, detail, and quality dependent on the type and findings of the audit, Reports should be precise, concise, and delivered in a timely manner.
- Ensure appropriate assessment of issues, and timely execution, closure, and effectiveness of CAPAs in response to supplier audit findings such that suppliers maintain compliance with Arrotex quality standards.
- Develops and directs Auditors including direct report(s), staff supporting audits from other Arrotex offices
- Advises on and leads the engagement of third-party auditors when required to cover remote geographies.
- Develop policies, procedures, systems, and metrics for supplier audits.
- Maintain and continuously improve processes and procedures to ensure efficient and compliant ways of working.
Educational Qualifications And Experience
- 10 years experience in Quality Assurance, or a related compliance role, in the pharmaceutical industry.
- Extensive Lead Auditor experience.
- Experience supporting pharmaceutical manufacturing, packaging, and/or testing operations in a technical or quality oversight capacity. Gained either in a manufacturing facility or by supporting third-party manufacturers/contract pharmaceutical manufacturers.
- Someone who has experience in a multinational company and has been exposed to UK/EU and FDA audits at least as an auditee Also experience with Sterile and Non-Sterile would be relevant
- Tertiary qualification in Chemistry, Pharmacy, or a related Science or field.
- Formal Lead Auditor certification
