Site Lead Auditor

hace 3 semanas

Madrid, España ALK-Abelló A tiempo completo

W

**e are looking for a new Site Lead Auditor in ALK**

ALK's aspiration is to become the world leader in allergy by helping as many people with allergy to a better life by providing options of prevention, diagnosis and treatment of allergy.

**Title: S**ite Lead Auditor

**Reports to**: QA Director

**Job Purpose: L**ead the GMP and Regulatory audit activities (Regulatory, Internal, Partner and Supplier). This position is instrumental in supporting the site efforts to ensure ongoing compliance.

**Main Duties**
- Organize and perform Quality Assurance/Regulatory Compliance audits at the site, contract manufacturers and supplier sites in a manner that will provide for clear identification of deviations from cGMPs and other regulatory requirements
- Consult with Director of QA concerning audit observations and corrective actions, compliance deviations and policy matters.
- Conduct independent audits (System and Walk-through).
- Provide guidance and recommendations as necessary to ensure that audited groups implement corrective actions.
- Evaluate the acceptability of the contractor/vendor/supplier from a Quality Assurance/Regulatory Compliance point of view and make recommendation to senior management.
- Participate as part of the site inspection time in external audits (Regulatory, Corporate QA and Partner).
- Management of Quality Agreement with contract manufacturers and suppliers.
- Support Continuous Quality improvement initiatives
- Provide GMP quality expertise, advice and/or assistance across the organization as required

**Education**
- University degree in Chemistry, Pharmacy, Biology or equivalent

**Work Experience**
- Minimum of 5 years’ experience in the pharmaceutical/biotech industry and with a thorough knowledge of quality systems, GMP and regulatory requirements including FDA.

**Competencies**
- Must have strong cGMP (EU & FDA regulations) knowledge
- Must have technical knowledge of Finished Pharmaceuticals/Biologics manufacturing and Laboratory Operations
- Ideally experience in Medical Devices
- Strong interpersonal and leadership skills in dealing with a variety of cultures on non-routine matters in stressful situations, can deal organisational complexity and ambiguity
- Fluid in the communications (both written and spoken) in English
- Experience working with Contract Manufacturers preferred

ALK is located in the business area of Ciudad Lineal, close to the centre of Madrid. We have quick access to the Hermanos Garcia Noblejas and Ascao metro stations and we also have a wide bus connection. The manufacturing site is located at Calle Miguel Fleta 19 while the Business Support area is in an adjoining building located at the Avalon Business Park.

ALK, among other benefits, has a canteen where the employees can have breakfast and lunch every day and offers days of teleworking as part of its social benefits.

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