Two Opportunities in Pharma Automation: Quality Manager and Documentation

Job-Link A/S
Two Opportunities in Pharma Automation: Quality Manager and Documentation

TWO Exciting Opportunities in Pharma Automation Quality and Compliance
Job-Link is seeking skilled professionals for two key roles within the Automation Department of a leading pharmaceutical client in Zealand, Denmark:​

• Quality Manager for Pharma Automation (PM / QM / PQM):
  We are primarily seeking a Project/Quality Manager with experience in IT and Automation Quality, particularly related to GAMP and S88 standards (for sys such as 800xA, Siemens, Sattline, DeltaV depending on your strengths).​
• Quality Documentation and Compliance Specialist (CSV / CSA / CQV / or similar)
  We also welcome applications from candidates with at least 3 years of pharmaceutical experience in CSV / CSA / CQV, who are interested in focusing on documentation and compliance review within the department.​
  (eg. PLC and SCADA)

About the job:
Key Tasks and Responsibilities

• Quality Management in Pharma Engineering Projects:
  • Lead and coordinate quality activities for cross-disciplinary pharma engineering projects.
  • Develop and implement verification strategies, for aligning with customer QMS and validation concepts, relating to Pharma Automation related IT Projects.
• Manage Suppliers:
  • Facilitate and coordinate supplier management activities.
  • Guide, review, and ensure compliance with suppliers' quality deliverables.
• Team and Process Coordination:
  • Actively contribute to the department's project management team.
  • Collaborate with other disciplines to ensure compliance with relevant codes, regulations, and project procedures.
• Project Oversight:
  • Review team deliverables to ensure quality standards are met.
  • Take financial responsibility for the quality related deliverables within the project.

Qualifications, Skills and Personal Qualities:(If you have other related skills, to the same effect and feel confident that you would be a close match, then please go ahead and send us your CV, in many cases a position can be tailored to your unique combination of skill-set, if relevant to the overall department needs)

• Qualifications and experience
  • Degree in engineering (e.g. automation, process, chemistry, biotechnology, pharmaceutical production, or a relevant field).
  • GMP / GAMP knowledge and experience
  • Minimum of 3 years of experience with quality management and project execution from the life sciences or biotech industry.
• Professional Skills:
  • In-depth knowledge of quality planning, verification, and validation.
  • Strong experience with project execution in engineering environments.
  • Fluent in spoken and written English.
• Personal Attributes:
  • Strong at problem-solving and collaboration.
  • Results-oriented and enthusiastic approach to work.
  • Thrives in a fast-paced environment with multiple project interfaces.
  • Builds strong, trusting relationships with all stakeholders.
  • Good at open communication.

• Not needed but nice to have knowledge about:
  • Danish at any level
  • S-88
  • 21 CFR Part
  • Batch production and related requirements in the pharmaceutical industry

The job is a full-time position on a contract of 1-3 years, with possibilities of extension or a steppingstone for further opportunities.
We invite you to apply and join our client’s highly professional team.
We can also accept consultants through their own company.

Please add your CV by clicking below.

For further information about the vacancy please contact,

If you have any questions regarding this jobposting, please contact Donny Mistarz
Donny@job-link.dk
Tlf.: 40602022
Application deadline:
As soon as possible