Associate Director, Microbiology European Compliance Specialist

Associate Director, Microbiology European Compliance Specialist

Teva

Amsterdam, Netherlands

Job Description

JOB PURPOSE

Ensure that each site within the region receives the right level of support to maintain and enhance GMP compliance, to solve quality related service issues, to identify areas of improvement for quality operational performance in line with business needs and in accordance to TEVA standards.

Foster and develop onsite Quality culture.

MAIN ACCOUNTABILITIES

  • Act and behave in accordance to TEVAs values and leadership standards;
  • Active Member of the EU Regional Quality Leadership Team, point of contact to Global Corporate Compliance according to defined responsibilities;
  • Act as primary point of contact for the Sites and support each site of the region for GMP compliance and service issues;
  • Partner with the Site Quality functions and Supply Chain teams to ensure continuous improvement of compliance and performance to provide best possible availability of products to the patients;
  • Work with the sites to remediate any gaps identified either in compliance or in service, if quality related;
  • Ensure together with the Members of the Regional Leadership team at all Sites within the EU Region that the corporate Quality Management System (QMS) is implemented and the local Quality Management Systems is up to date;
  • Support the Sites that a Quality risk management is implemented, to assess, control, communicate and review risks to the quality of the medicinal products;
  • Support the management of the Regional Quality Council (scheduling, preparation, review, conduct, recording, follow up) and other meetings as applicable;
  • Provide adequate support to timely availability of data to the reporting portals (e.g. BI system, etc.) and provision of regional reports;
  • Participate in cross functional meetings where EU Regional Quality has to be represented, as agreed with management;
  • Partner with the sites and support to remediate on time and in full any gaps identified in compliance, towards the QMS or in quality related service as but not limited to:
  • Site compliance reviews;
  • Investigation and remediation of non-compliances to corporate QMS;
  • Service issue management – work with site to manage and track remediation activities with regard to quality related service issues;
  • Oversight to the implementation and evaluation of effectiveness of the corrective and preventive actions;
  • Quality risk assessments;
  • Inspection readiness;
  • Complaint management;
  • Adherence to corporate quality metrics in line with global targets;
  • Installation, validation, and maintenance of information systems in accordance with regulatory and Teva Global requirements;
  • Data integrity governance;
  • others as per assignment and sites request;
  • Support continuous improvement of compliance and performance to provide best possible availability of products to the patients;
  • Support the sites that data integrity requirements are met;
  • Cooperate with other functions within Quality projects and their rollout;
  • Act as a quality SME and support global compliance initiatives upon request;
  • Participate in regulatory inspections and audits upon request;
  • Foster and develop on site Quality Culture;
  • Foster knowledge sharing among sites within the Region;
  • Other projects as per assignment.

Qualifications

KNOWLEDGE

  • Master Degree in Chemistry, Biology, Microbiology, Pharmacy or similar;
  • Demonstrated knowledge in cGXP regulations;
  • Sterile and/or Microbiology expert/SME;
  • Understanding of the different aspects of quality functions like QC, QA, Quality Systems, Compliance, Documentation etc.;
  • Knowledge of regulatory standards and guidance in Pharmaceutical Industry;
  • Knowledge of Quality Systems, product types and manufacturing operations;
  • Knowledge of MRP Systems and software platforms typically used by TEVA (TW; NtM, Qualiteam, etc.);
  • Ability to understand and execute against Teva Quality Management System;
  • Ability and experience in processes mapping, systems structuring;
  • Fast analyzing capability, Problem solving and good team work skills;
  • Proactive orientation;
  • communication skills: Constructive Positive Solution Driven Person.

EXPERIENCE

  • 10+ years working experience in GMP environment, continuous professional development;
  • Experience in managerial tasks;
  • Collaboration with internal Compliance projects;
  • Exposure to International working environment and customer orientated;
  • Fluent in English;
  • Must travel ( up to 50 %).

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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