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Vacature: Audit and Inspection Manager

Werkgever:Surge for Sciences
Plaats:Geleen

Functie

Headquartered in Switzerland, our client has production, R&D and business sites around the world, including Europe, North America, and Asia. Currently there are several positions available, among which the Audit and Inspection Manager.

In this position, you look after any inspection / audit related activities on site. These include all regulatory inspections, customer inspections, and internal inspections. The Audit and Inspection Officer supports the facility for any unexpected regulatory or customer inspections via carrying out routine internal audits. The team also supports the supplier qualification audits, when required by the Global Supply Quality Systems.

Delivery of services in this role will include, but not be limited to:

Audit / Inspection Support:

• Serve as an internal auditor for the site. Preparation of Internal Audit Reports, Observations and CAPA follow-up.

• Support the Audit and Inspection manager to plan and execute internal audits. Support in maintaining an audit calendar that’s visible to relevant Department managers.

• In addition to the routine internal audit, perform QA routine walk-around checks in the facility.

• Ensure compliance to the SOPs and Lonza Global Quality Standards.

• Ensure operations and records meet established requirements of cGMPs.

• Actively participate in the preparation, execution and follow-up for audits from Global Quality Auditors.

• Maintain the audit records. Work with the Department Managers to assign observations to the relevent subject matter experts (SMEs).

• Ensure audit / inspections Corrective and Preventive Actions (CAPAs) are completed to the agreed timeframe and effectiveness completed to prevent recurrence.

• Involvement in the site for the appropriate support of the preparation, conduct and follow-up of external audits.

Audit and Inspection Readiness Support:

• Work with team members and Department Managers to evaluate and identify gaps on regulatory guidelines.

• Identify improvement opportunities in the audit related activities.

• Carry out the improvement related activities when required.

Functie-eisen

• Knowledge of auditing processes, flow, and requirements.

• Good communications skills with both written and verbal. Experiences with regulatory and customer interaction for audit.

• Good GMP and Quality knowledge.

• Knowledge of regulations in multiple GMP area(s); ability to translate regulations into operational requirements (21 CFR 210, 211, 600s, 1271, as well as Eudralex Volume 4 Part 4 for ATMP Manufacture).

• Technical writing and reviewing of observation reports and responses.

• Attention to detail and ability to influence others in a team environment.

• Action-oriented and customer-focused and skilled in decision-making, a team player in building relationships, problem solving, conflict management, planning and organizing, and analytical thinking.

• Knowledge of Cell and Gene Therapy Products and Processes.

Informatie

Robin Bisschoff +31 614795647

Solliciteren

Robin Bisschoff +31 614795647