Your responsibilities

In your role as Head of Manufacturing (m/f/d) in our company, you will play a key role in implementing, ensuring, and further developing manufacturing processes in the context of secondary packaging on a contract basis. Your tasks will also include organizing and monitoring warehouse activities and ensuring the proper storage of medicinal products in a GMP-regulated environment in accordance with Section 12 of the German Medicinal Products Act (AMG).

Your responsibilities will include:

  • Participation in and approval of qualifications and validations relating to the manufacturing area and GMP storage, e.g., qualification of operating rooms, technical equipment
  • Preparation and review of work instructions within the area of responsibility
  • Approval of manufacturing instructions in accordance with § 13 AMWHV (German Medicinal Products for Human Use Ordinance), as well as ensuring proper compliance with the manufacturing instructions and proper recording and archiving.
  • Ensuring proper labeling in accordance with § 15 AMWHV
  • Ensuring that confusion or mixing of medicines, packaging materials, labeling materials, etc. is avoided in the area of responsibility
  • Validation of manufacturing processes
  • Monitoring the maintenance, servicing, and calibration of technical devices and equipment that are relevant to the area of responsibility
  • Ensuring operational processes within the department, including general management tasks and conducting training sessions
  • Support for customer-specific projects and for establishing individual manufacturing processes in accordance with customer-specific requirements

Your profile

  • Work experience in secondary packaging of pharmaceuticals/production of pharmaceuticals
  • Knowledge of regulatory requirements in the pharmaceutical environment (GMP guidelines, AMG, AMWHV)
  • Initial experience in performing process validation and equipment qualification
  • Structured, independent, and conscientious approach to work
  • Confident use of MS Office (especially Word, Excel, Outlook)
  • Strong teamwork and communication skills
  • Very good written and spoken German, good English skills an advantage
  • Solution-oriented action rounds off your profile
  • Initial experience in a management position and knowledge of the GDP-regulated environment are desirable.

 

Start date: immediately

Type of employment: Full-time (40 hours/week)

Location: Schiffweiler – on site

 

We look forward to receiving your application!

Email: engler@1azpharm.com