Head of Quality Control (m/f/d)

  • Skopje 1000, Skopje 1000, North Macedonia
  • Full-time

Company Description

Gerresheimer is a leading global partner to the pharma and healthcare industry. Since its foundation in Germany in 1864, the publicly traded company now operates worldwide with 10,000 employees and generates revenue of €1,4 billion. Gerresheimer’s product portfolio includes pharmaceutical packaging and products for the safe and simple administration of medicines, i.e. insulin pens, inhalers, pre-fillable syringes, injection vials, with manufacturing facilities in Asia, Europe and North-and South America.
Gerresheimer will build and establish a new facility in Skopje, North Macedonia as part of the Plastics & Devices Division manufacturing and assembling a variety of precision molded plastic parts for various applications in the medical industry.

Job Description

  • Leading the Quality Control in order to achieve the set plan specifications (e.g. ConQ, personnel costs, personnel efficiency, etc.) with continuous development of the entrusted personnel and fulfilment of the regulatory requirements
  • Ensuring the onboarding, assessment and development of employees by the subordinate executives
  • Long-term planning in terms of staff, equipment, processes, etc. (e.g., OPSP, CAPEX) 
  • Assurance of an effective customer communication 
  • Proactive cooperation with internal and external interfaces (e.g. plant management, production areas, HR, customers) and sister plants
  • Independently planning and implementing investments for extensions and optimization 
  • Ensuring up-to-date and audit-compliant QM documentation 
  • Responsible for continuous improvement (technologies and work organization) and coordination of GMS activities 
  • Cost centre responsibility
  • KPI responsibility and ensuring reporting 
  • Release of the CoA for pharmaceutical products 
  • Independent support of internal and external audits 
  • Participation in internal and organizational projects (e.g. system processes)
  • Personnel management including all individual tasks (initiate disciplinary measures, assessment of employees, personnel development, etc.) 

Qualifications

 

  • Minimum of 5 years’ experience in Quality management in a manufacturing facility. Preferable to have injection molding plastic experience or medical device and / or pharmaceutical packaging products experience
  • Bachelor degree or above, preferable to major in Scientific, Engineering or related field, Six Sigma, Black Belt, Green Belt is a plus
  • Macedonian: business fluent (required), English fluent (required), German skills would be an advantage
  • Leaderships skill and experience in leading, qualifying and developing a team
  • Experience with lean manufacturing, 21CFR (= Code of Federal Regulations) 820/210/211; ISO 9001:2000, ISO 13485:2003, 2016 and auditing experience
  • Profound knowledge of SPC and SQC applications in a manufacturing environment
  • Further IT skills in e.g. MES, SAP, MSOffice
  • Expertise in a clean room environment would be an advantage
  • Stable, solid personality with strong leadership skills able to quickly establish credibility internally and externally
  • Strong communication skills both internally and externally utilizing networking and exchanging best practices
  • Possesses intercultural sensitivity and understanding, with the ability to work collaboratively an international business environment
  • Willingness to international business travel within the first month of the employment as onboarding will be mainly in our facilities in Germany for around three month
  • Employment will be with our company in the Republic of North Macedonia
  • Reporting line to the Head of Plant Quality of the Skopje plant

 

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