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Associate Quality Manager (m/f/d) (EN)

[5524]
Risk and CAPA managements, GDP, cGMP, Quality Management, Pharma-

Our client is one of the most innovative globally operating pharmaceutical companies and has been awarded several times as a TOP employer. We are looking for a committed and motivated personality as Associate Quality Manager (m/f/d) Your tasks ·Ensure that a Quality Management System is implemented and maintained in the local market, tasks i. e.: oActs as support and back-up of Quality Manager in accordance with Market regulatory requirements oGDP and Local regulations impact assessment and implementation oSupports and ensures deviation investigations and CAPA management impacting the German market oSupports the implementation of the Change Controls impacting the German market oReviews the APQRs, as required per local regulations oPreparation and support of the Quality Management Review/Quality Council of the Market oReports quality metrics and monthly market updates, prepares Deep Dive Analysis for missed metrics ·Ensures implementation of following Quality Operations, i. e.: oSuppliers management oversight: Quality Agreements, approving any local subcontracted activity which may impacts product quality, evaluate and confirm the overview of the supplier qualification status oCustomers oversight: periodic customer License verification oProduct Quality status and batch release or approval to the market oSupport compliance/quality issues with the impacted market team  ·Support implementation of requirements in the Local DE Distribution Centers ·Quality Risk Management ·Inspections and Regulatory Surveillance ·Etc. Your qualifications ·first year(s) experience in the pharmaceutical health care industry and dealing with regulatory agencies (in one of the following areas: Quality control / Quality Assurance / Diagnostics / manufacturing / pharmaceutical development / Drug Regulatory Affairs) ·basic knowledge and experience in pharmaceutical health care operations, quality control, distribution and international regulations are essential ·Proficient in cGMPs, cGDPs, local pharmaceutical regulations and regulations promulgated by EMA or equivalent regulatory Agencies; requirements for pharmaceutical products distribution ·Good verbal, written and presentation skills in English ·Innovative, creative and utilize available resources ·IT knowledge in (M365 and SAP) and in Quality Systems ·Team oriented worker with excellent interpersonal skills ·Ability to actively participate in projects within a multi-disciplinary environment, inquisitive, science technology oriented individual but practical ·Ability to collaborate and communicate directly and to actively participate in cross - functional and cross regional teams ·Negotiating skills for interfacing with market functions ·Ability to effectively communicate ideas and influence others to accomplish challenging goals and objectives If you feel attracted by this job feel free to get in touch with Bettina Cöppicus at Optares via bettina.coeppicus@optares.de or by phone at +49 441 21879-18

Our client is one of the most innovative globally operating pharmaceutical companies and has been awarded several times as a TOP employer.

We are looking for a committed and motivated personality as

Associate Quality Manager (m/f/d)

Your tasks
  • Ensure that a Quality Management System is implemented and maintained in the local market, tasks i. e.:
    • Acts as support and back-up of Quality Manager in accordance with Market regulatory requirements
    • GDP and Local regulations impact assessment and implementation
    • Supports and ensures deviation investigations and CAPA management impacting the German market
    • Supports the implementation of the Change Controls impacting the German market
    • Reviews the APQRs, as required per local regulations
    • Preparation and support of the Quality Management Review/Quality Council of the Market
    • Reports quality metrics and monthly market updates, prepares Deep Dive Analysis for missed metrics
  • Ensures implementation of following Quality Operations, i. e.:
    • Suppliers management oversight: Quality Agreements, approving any local subcontracted activity which may impacts product quality, evaluate and confirm the overview of the supplier qualification status
    • Customers oversight: periodic customer License verification
    • Product Quality status and batch release or approval to the market
    • Support compliance/quality issues with the impacted market team 
  • Support implementation of requirements in the Local DE Distribution Centers
  • Quality Risk Management
  • Inspections and Regulatory Surveillance
  • Etc.

Your qualifications

  • first year(s) experience in the pharmaceutical health care industry and dealing with regulatory agencies (in one of the following areas: Quality control / Quality Assurance / Diagnostics / manufacturing / pharmaceutical development / Drug Regulatory Affairs)
  • basic knowledge and experience in pharmaceutical health care operations, quality control, distribution and international regulations are essential
  • Proficient in cGMPs, cGDPs, local pharmaceutical regulations and regulations promulgated by EMA or equivalent regulatory Agencies; requirements for pharmaceutical products distribution
  • Good verbal, written and presentation skills in English
  • Innovative, creative and utilize available resources
  • IT knowledge in (M365 and SAP) and in Quality Systems
  • Team oriented worker with excellent interpersonal skills
  • Ability to actively participate in projects within a multi-disciplinary environment, inquisitive, science technology oriented individual but practical
  • Ability to collaborate and communicate directly and to actively participate in cross - functional and cross regional teams
  • Negotiating skills for interfacing with market functions
  • Ability to effectively communicate ideas and influence others to accomplish challenging goals and objectives

If you feel attracted by this job feel free to get in touch with Bettina Cöppicus at Optares via bettina.coeppicus@optares.de or by phone at +49 441 21879-18

map München, Deutschland date_range 12.04.2022 update Temporary
Qualitätswesen Qualitätsmanagement CAPA GMP GDP quality management


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