Quality Control Specialist at Freitag Gruppe GmbH and Co KG
Germany, Colorado, Germany -
Full Time


Start Date

Immediate

Expiry Date

31 Jan, 27

Salary

50000.0

Posted On

02 Nov, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Yes

Skills

Industry

Biotechnology

Description

We are a world-leading company dedicated to improving people's lives through cannabis.   At Canopy Growth, quality, consistency, and trust define everything we grow, produce, and deliver. From cultivation to the consumer, we pursue a long-term perspective and have the ambition to set industry standards.   We are looking for principled, motivated people who want to do meaningful work and help shape the future. We invest in our employees, support their development, and value the diverse backgrounds, experiences, and perspectives they bring.   We believe the best this industry has yet to achieve is still ahead of us – and we want to lead it there. Join us. We are looking to fill the position of Quality Assurance Specialist (m/f/d) as soon as possible, who will primarily work in the quality control department within the context of pharmaceutical manufacturing .

 

Your tasks:


  • Participation in quality investigations, complaints, recalls and other quality-related activities, taking into account patient, product and occupational safety.
  • Ensuring compliance with GMP guidelines, quality standards and data integrity requirements in the area of ​​quality control (QC).
  • Conducting, evaluating and documenting stability studies and analytical tests.
  • Participation in the release of raw materials, packaging materials, intermediate products and bulk goods, as well as support for batch certification.
  • Processing and evaluation of deviations, OOS/OOT results, and implementation and follow-up of CAPA measures.
  • Creation, review and maintenance of specifications, test methods, work instructions and QC documentation in accordance with GMP requirements.
  • Planning, coordination and documentation of method validations, verifications and method transfers, as well as support for external testing laboratories.
  • Support with audits, supplier qualifications, change control processes, product quality assessments and quality indicators.

• You are responsible for ensuring, maintaining, and improving our internal quality system in accordance with GMP guidelines.
• In particular, you will conduct QA testing of microbiological monitoring data.
• You will create trend reports based on the monitoring data and, if necessary, oversee resulting CAPA measures. 
• You will support the development of process optimizations related to hygiene-related topics in the GMP environment.
• To this end, you will maintain constant communication with other departments, serve as a contact person for quality-related issues, and conduct training sessions.
• Maintaining and reviewing data in the GMP environment are also part of your responsibilities, as is issuing and managing documents.
• You will provide QA support for new projects in the GMP environment, always keeping quality-relevant aspects in mind.
• You will review various documents such as SOPs, qualification and validation documents, logbooks, and other GMP documentation.
• You will oversee the creation of risk analyses in collaboration with the relevant departments.
• You will support the implementation of CAPAs as well as the handling of deviations and change controls.


Responsibilities
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