Audit Program Manager - Quality Assurance IVD (m/f/d)
abbot
Istanbul, Turkey
son 23 saat

At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world in nutrition, diagnostics, medical devices and branded generic pharmaceuticals that create more possibilities for more people at all stages of life.

Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

In Germany, Abbott has more than 3,000 employees working in manufacturing, research and development, logistics, sales and marketing.

They are located at Abbott s German headquarters in Wiesbaden and its sites in Hanover, Neustadt am Rübenberge, Wetzlar, Eschborn and Witten.

Alere in Cologne and Jena is now Abbott.

Abbott Diagnostics Division (ADD) is looking for an

Audit Program Manager - Quality Assurance (w / m / d) home-based for In-Vitro-Diagnostics Audits

field based out of any European country in which Abbott has an affiliate such as e.g. Germany, Italy, Turkey, Czech Republic, The Netherlands, Spain, etc.

This position administrates regulatory compliance activities related to the Internal Audit Program. The position is key in the facilitation / execution of the internal inspection process and ensures the Internal Audit Program across the Abbott Diagnostic Division (ADD) Sites / Commercial Affiliate Sites serves to identify Quality System improvements.

Independently conducts assigned audits of Suppliers and Third Party Manufacturers (TPM’s) to assess compliance to all applicable external standards and regulations as well as Abbott Quality System requirements at a standard commensurate with regulatory external audits.

Main Responsibilities :

Plans and conducts internal audits across the ADD Sites / Commercial Affiliate Sites to assess compliance to all applicable External Standards and

Regulations as well as Abbott Quality System requirements

Identifies compliance risks to current regulations and guides the sites in the planning and execution of Quality System improvements

Prepares and implements Internal Audit schedules spanning the ADD manufacturing sites, Commercial Affiliate sites, as well as the scheduling and performance of Supplier / TPM audits

Uses current regulatory trends to identify potential compliance risks or opportunities for improvement in ADD's Quality System

Conducts internal audits at a standard commensurate with regulatory external audits

Leads initiatives to address compliance gaps across the Commercial Affiliate Sites. This may include the development of CAPA plans and resulting follow-up guidance activities in support of the Commercial Affiliates to attain the required level of compliance

Reports progress of audits within Sites and to Division personnel as appropriate

Provides guidance to applicable Inspection-Readiness activities across ADD Sites

Performs topic specific SIM audits at ADD Sites as requested by management

Reports audit findings in a timely manner

Generates and reports internal audit metrics to Site and Division Management

Maintains files and documentation associated with internal and external inspections

Participates as SME in audits; provides compliant, and strategic solutions to complex quality issues

May assist with audit support activities during external audits of Sites

Leads projects that are cross-functional in scope; directly influences project direction and scope; champions new initiatives and acts as the catalyst for change within and potentially across Divisions

Maintains and demonstrates understanding of global standards, regulations and regulatory bodies

May assume managerial responsibilities as needed

The above statements are intended to describe the general nature and level of work that is being performed. Other duties may be performed

Your profile :

  • Apprenticeship or Bachelor's degree in Life Science; Engineering or closely related discipline is required. Experience in the medical device / pharmaceutical industry
  • Knowledge of Good Manufacturing Practices (GMPs), Quality System standards and regulatory requirements such as 21 CFR 820;
  • ISO 13485; IVDD (in-vitro-Diagostic Directive); etc.

  • Trained in auditing techniques; Certified Auditor qualification or equivalent is required
  • Experience in internal and external (TPM) audits and technical file content
  • Excellent written and verbal communication skills
  • Fluent English and German
  • Travel time 35-40% in Europe, Asia and Latin America
  • Abbott Germany has a range and variety of jobs on offer in a positive and dynamic environment that allows you to maintain a healthy work-life balance.

    We provide development opportunities as part of our comprehensive Talent Management Program. Your contribution to the company’s success will be rewarded with a competitive salary package.

    We offer comprehensive benefits to suit the lifestyles of all our employees, from a retirement plan that is far above market average, a save-as-you-earn program, to educational scholarships for children, and health management initiatives for staff and their dependents.

    Do you like the sound of this job and think you’ve got what it takes? Then send us your CV today. We look forward to receiving your application.

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