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QA Compliance Leader / Qualified Person (m/f/x)

  • Location: Hesseneck
  • Salary: Up to €101000 per annum + negotiable per year
  • Job Type:Permanent

Posted etwa ein Monat her

  • Sector: Pharmabranche
  • Contact: Sebastian Gotzler
  • Contact Email: s.gotzler@sciproglobal.de
  • Start Date: asap
  • Expiry Date: 19 May 2022
  • Job Ref: RA_2022_15_1650377586

QA Compliance Leader & Qualified Person (m/f/x) | Personal Health Care

In this position you will be mainly responsible for developing and implementing a 2-year compliance master plan. You will lead and support internal and external audits of medicines and food supplements. Due to strong growth, the company has a high number of product initiatives in the coming years. The newly created role is critical to the successful implementation according to internal and external standards and regulations. You will work across the entire site across departments and utilize the compliance networks within the group.

What will your tasks as "QA Compliance Leader & Qualified Person (m/f/x)" be?

  • Develop a 2 yrs Site Compliance Masterplan and execution with focus to manage growth in Personal Health Care and support/ensure full external compliance for all categories
  • Responsibility for the release of products in the function of the Qualified Person according to §15 AMG, including all product-specific and release-relevant QA processes
  • Take over Leadership or provide strong support in external audits for Drugs, Food Supplements
  • Capable of leading and driving change in a team approach
  • Build a strong network across the site and within the group to ensure reapplication, benchmarking, and full involvement of all stakeholders

Your requirements as "QA Compliance Leader & Qualified Person (m/f/x)"?

  • University degree in Pharmacy
  • Registration as Qualified Person according to §15 AMG
  • Experience in regulated business, ideally in BoH regulations for Drugs, Food Supplements, Cosmetics
  • Passion for shaping fully compliant processes across the site
  • Focus on all critical GMP processes e.g. Validation (Processes Making and Packing, C&S, CSV/DI), Internal Audits/QPHA, Risk Management, Change Management, Investigations
  • Strong technical skills and communication skills - fluency in German & English
  • Strong leadership skills and emotional intelligence

Information about our client:

Our client was founded over 150 years ago and has developed into the world's leading consumer goods company with a portfolio including some of the most trusted brands on the market. Their product portfolio includes 60+ individual brands with one of them being "Personal Health Care", where this position will be located. The client is operating in more than 100 countries worldwide and has almost 100.000 employees.

I look forward to your application!