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Experience HELM as a unique family business and an attractive employer. Through a constant exchange of ideas, our ultimate goal is to offer our customers future-oriented solutions within our global network. At any time, in any place. This allows us to work proactively and think long-term - in operations, quality management, process optimization, product development and distribution. We are innovation drivers, possibility makers and a reliable partner, all in one.

Manager Quality Product (m/f/d)

Date:  Jun 30, 2024
Location: 

Carnaxide, PT, 2790-045

Business Unit:  Pharma
Job Function:  Quality Management / HSE
Level of Experience:  Mid-Career

For our Quality Assurance department in our Pharma Business Unit, we are looking for a Manager Quality Product (m/f/d) in our Portugal’s Office in Carnaxide. 

 

Your tasks: 

 

  • As part of your responsibilities, you will be involved in the preparation, review, and monitoring of delineation of Technical Quality Agreements with external contractual partners. 

  • Your role will include the implementation and monitoring of external document and process change procedures, ensuring adherence to quality standards. 

  • You will be responsible for recording, processing, and evaluating non-conformities to maintain and enhance overall product quality. 

  • Take charge of the management of Corrective and Preventive Actions (CAPAs) to address issues and continuously improve processes within the organization. 

  • A key aspect of your role involves preparing and evaluating Product Quality Reviews to ensure the ongoing quality and compliance of products. 

  • Engage in the creation, review, and maintenance of product specifications to uphold the highest standards of quality and compliance. 

  • Furthermore you conduct thorough reviews of batch-specific release documentation, contributing to the release of high-quality products to the market. 

  • Play a crucial role in the implementation of recalls, ensuring swift and effective response to maintain product safety and compliance. 

  • Your responsibilities will extend to the management, maintenance, and archiving of GxP documents to uphold regulatory standards. 

  • Contribute to the organization's commitment to quality by conducting audits at contracting companies, suppliers, and service providers worldwide, based on the currently applicable regulations and requirements, such as GMP, GDP, GLP, and ISO. 

 

Your profile: 

 

  • With a Bachelor's or Master's Degree in Lifescience, specifically in areas such as Pharmaceutics, Biology, or Chemistry, you bring a solid educational foundation to this role. 

  • You bring experience in Quality Assurance within the Pharmaceutical Industry according to EU and US requirements. 

  • Experience with FDA requirements will be highly valued. 

  • You enjoy working in an international environment and will be happy to share your knowledge within the team.  

  • Fluency iEnglish is a key requirement for this position, as effective communication is essential in ensuring the highest standards of quality and compliance are upheld. 

Every day, each one of us contributes to HELM's success with competence, the highest expertise and unique service. We reward this commitment - not only with international opportunities, possibilities for seminars and further training but also with benefits that offer optimal conditions to reach the perfect work-life balance.

Interested?
Then please apply with all necessary documents via our application portal.

Apply now »