QA Systems Manager

vor 2 Wochen

Aesch BL, Basel-Land, Schweiz unisite ag Vollzeit
unisite ag is a service provider in the field of Employer Branding & Talent Management. We provide consulting services to clients in the chemistry, pharmaceutical, biotech, medical device, and life sciences industries.

Our client, Pentapharm AG, is an international and innovative company and is part of the DSM Firmenich Group.

They employ approximately 100 people and specialize in the production and global sale of active ingredients for the pharmaceutical and diagnostics industries.


On behalf of our client, we are currently looking for a:
QA Systems Manager (M/F/d)

Location:
Aesch, BL

Position

We are seeking a highly motivated individual to join our team as a QA Systems Manager (M/F/d).

In this role, you will maintain a compliant Quality Management System (QMS), further develop the electronic QMS, and ensure timely investigations and resolution of issues through scientific princi-ples and root cause analysis.

Tasks

  • Manage and enhance the electronic QMS, ensuring its effectiveness and compliance
  • Oversee the Corrective and Preventive Action (CAPA) process to address quality issues promptly and effectively
  • Lead the training system, including onboarding, offboarding, and planning GMP training sessions
  • Conduct thorough investigations into customer complaints related to product release, considering all manufacturing processes, quality testing, and customer requirements
  • Maintain Quality Agreements with customers and subcontractors
  • Provide support for supplier qualification process management
  • Plan and oversee the external audit program for suppliers and lab contractors
  • Evaluate quality aspects of new change control proposals and support the QA department with special projects as needed
  • Identify and implement changes in established processes to enhance quality standards
Qualification

  • Minimum MSc in Biology, Chemistry, Pharmacy, or related fields, or a Master's in Quality
  • 2+ years of experience with a proven track record in a GMP or ISO production environment
  • Proficiency in product classification, definition of applicable standards, and conformity assessment procedures
  • Proficient with computer systems and strong recordkeeping and documentation abilities
  • Selfdriven and resultsoriented, with the ability to work independently
  • Excellent communication and presentation skills as well as exceptional organizational and detailoriented skills
  • Strong communication skills in German and English

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