Senior Compliance And Auditing Officer - Switzerland

Switzerland  ‐ Onsite
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Senior Compliance and Auditing Officer - Switzerland

A major pharmaceutical organization has a fantastic opportunity for a Senior Compliance and Auditing Officer to join the team based in Switzerland. You will provide support to the GMP Compliance and Auditing team by ensuring the correct and timely sharing of information within the Division and providing oversight to the gap assessment process required to each site.

The Role:
*Provide oversight to the divisional process for the collection and assessment, both at divisional and site level, of any observation raised by any HA at any site
*Ensure adequate metrics are in place to monitor the execution and outcome of the gap-assessment vs HA observations and to monitor the implementation of the corresponding CAPAs
*Ensure a timely escalation of any overdue CAPA according to the applicable procedures
*Be the single point of contact for the Group functions in charge for the collection and dissemination of information concerning new and revised regulations, HA expectations and inspection trends.
*Share, by means of dedicated reports, the knowledge deriving from the point above and from independent regulatory intelligence activities within the division and with the sites.
*Co-Lead the Compliance Forum with the rotating site Compliance Head.
*Provide training to the auditors on new regulations/HA expectations, as appropriate.
*Timely execution of the gap-assessment vs HA observations and other GMP compliance gaps
*Accurate and timely monitoring of all the Divisional and site commitments vs HAs.
*Effective sharing of information and knowledge of Compliance related topics within the Division

Experience:
*Experience in GMP Compliance roles or equivalent and demonstrated exposure to HA inspections for more than 5 years
*Direct exposure to FDA or MHRA or IMB is required.
*Scientific degree
*Demonstrated knowledge of the most important GMP regulations is essential
*Sense of urgency without jeopardizing the quality of the output
*Interpersonal and communication skills (oral, written)
*Fluent English (spoken and written)
*Good knowledge/mother tongue of an additional language (e.g. German, Italian, Chinese) is desirable
*Please note you will be required to travel throughout Europe, US, China and India

A fantastic daily rate is on offer alongside an exceptional opportunity to join a major pharmaceutical organization based in Switzerland.

Please apply today with a covering letter highlighting your key skills and relevant experience aligned to this fantastic opportunity.
Start date
n.a
From
Quanta Consultancy Services
Published at
09.10.2012
Contact person:
Lee Mitchell
Project ID:
431501
Contract type
Freelance
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