Quality Specialist Biopharma

Date: Mar 22, 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.

Short Description

12-Month FTC

Position Summary

Executes 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, such as QMS uptake, product/supplier qualification and participation to audits and inspections. QC tasks include release of goods and product compliance checks, documentation issuance, verification, and updates. The position requires autonomous mode of working, with strong organisational and communication skills both internal to the company and external (customers)Collaborative interactions with supply chain and sales.

Responsibilities will include:

  • Release products based on a documentation verification and reg compliance
  • Ensures continuous qualification of existing products and supports development of new portfolios 
  • Validates manufacturer’s (CoA) and creates CoA’s for customers; as well as other certificates
  • Handles complaints related to product quality and oversees distribution 
  • Prepare and execute customer Quality Audits, Internal Audits, regulatory inspections and others;
  • Contributes to continuous improvement of the existing processes
  • Contributes to processes and procedures review and creations
  • Monitors validity of existing Actylis and Suppliers certificates (GMP/ GDP/ ISO/ etc.) (maintenance of Supplier Qualifications) 
  • Executes work in line with the established internal rules and SOPs 
  • Ensures application and execution of QMS in place

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.
  • Autonomous in task management and workload
  • Ability to perform complex tasks following established processes
  • Strong problem-solving skills
  • Familiarity with working in a distribution/ non-manufacturing company is preferred
  • Experience in working in cross-cultural teams in a global environment preferred
  • Ability to speak English fluently is required, other languages (German, Dutch, French) are a plus
  • Self-motivated
  • Excellent interpersonal relationship skills

Physical Demand

Supervisory Responsibilities

N/A

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 where necessary. The noise level in the work environment is usually moderate.