Quality Manager

Date: Feb 11, 2024

Location: Dusseldorf, Dusseldorf, DE, 40549

Company: Actylis

Actylis is a leading manufacturer and supplier of critical raw materials and performance ingredients serving the Life Sciences, Specialty Chemicals, and Agriscience industries.

 

We offer standard and custom ingredients through our rapidly growing portfolio of GMP and non-GMP facilities worldwide, and further choice through our strong sourcing hub network. This unique hybrid option blending manufacturing and global sourcing, combined with more than 75 years of sourcing and distribution experience makes Actylis the Partner of Choice.

Position Summary

Manages the quality assurance and quality control activities related to assigned products on daily basis, ensuring compliance to relevant regulations and customer requirements. Quality system management tasks are part of duties. The position requires autonomous mode of working, with strong organisational and communication skills both internal to the company and external (customers).

Responsibilities will include:

  • Responsible to release products based on a documentation verification, in compliance with applicable regulations and relevant quality standards;
  • Ensures continuous qualification of existing products and supports development of new portfolios (Product Supplier qualification for the business); ensures data management and its validity (respect of data integrity rules)
  • Validates manufacturer’s certificates of analysis (CoA) and creates CoA’s for customers; as well as other certificates (CoO etc.)
  • Collaborates with external laboratories for sample analysis when needed
  • Handles complaints related to product quality; oversees distribution service complaints and provides support;
  • Enforces regulatory compliance within the organization
  • Responds to internal colleagues for any type of technical product-related questions 
  • Participates in organization, preparation and execution of customer Quality Audits, Internal Audits, regulatory inspections and other;

Required Experience & Knowledge

  • Scientific background in Biology, Chemistry, Biochemistry or Biotechnology
  • 5+ years relevant experience in working with Quality Management Systems, including Quality Assurance and Quality Control
  • Knowledge of API GMP guidelines and practices, ISO 9001:2015 requirements and preferably other relevant quality standards (HACCP, ISO 22000, ISO 13485 etc.) is requested.

Physical Demand

Supervisory Responsibilities

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made.  The noise level in the work environment is usually moderate.

 

Office-based utilizing the companies’ office space 3 days per week and home based 2 days per week; the position requires a low level of travel, for internal meetings with team members or with customers.