MQA Support Specialist
vor 1 Monat
At FRESENIUS KABI, we are committed to excellence in our operations. Our team is dedicated to ensuring the highest standards in quality assurance and validation processes within the pharmaceutical industry.
Key Responsibilities:- Facilitate and assist the Validation department in executing various validations and qualifications.
- Develop and implement test strategies for Change Controls.
- Oversee and conduct requalification initiatives.
- Support the management of deviations, change controls, and CAPAs associated with qualifications and validations.
- Contribute to the creation and modification of Standard Operating Procedures (SOPs).
- Deliver essential training to team members.
- Conduct thorough investigations in production in response to quality complaints.
- Provide support to the MQA team in their daily operations.
- Possess a Master's or Technician degree, ideally in a technical or scientific discipline; relevant qualifications are a plus.
- Demonstrated experience with Root Cause Analysis methodologies.
- Background in the production or quality assurance of sterile pharmaceuticals.
- Familiarity with GMP standards in FDA-regulated environments.
- Knowledge of medical device regulations (MDD, ISO 13485).
- Exhibit a strong sense of responsibility and dependability.
- Possess excellent analytical and evaluative skills, with a focus on processes and quality.
- Show an affinity for automated systems and processes.
- Strong communication and teamwork abilities.
- Ability to work autonomously and decisively, demonstrating resilience and assertiveness.
- Fluent in both German and English, with strong written and verbal communication skills.
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MQA Support Specialist
vor 1 Monat
Friedberg, Hessen, Deutschland FRESENIUS_KABI VollzeitAbout the RoleAt FRESENIUS KABI, we are committed to excellence in the pharmaceutical industry. Our team is dedicated to ensuring the highest standards of quality and compliance in our operations. We are looking for a qualified individual to enhance our MQA support functions.Key Responsibilities:Facilitate and assist the Validation team in executing...
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MQA Support Specialist
vor 1 Monat
Friedberg, Hessen, Deutschland FRESENIUS_KABI VollzeitAbout the RoleAt FRESENIUS_KABI, we are dedicated to maintaining the highest standards in our production processes. Our team in Friedberg is integral to our global operations, and we are looking for a qualified individual to enhance our MQA support functions.Key Responsibilities:Facilitate and assist the Validation department in executing qualifications and...
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MQA Support Specialist
vor 1 Monat
Friedberg, Hessen, Deutschland FRESENIUS_KABI VollzeitAbout the RoleAt FRESENIUS KABI, we are dedicated to maintaining the highest standards in our production processes. Our facility has been a key player in the industry for over two decades, and we are looking for skilled professionals to enhance our team.Key Responsibilities:Facilitate and assist the Validation department in executing qualifications and...
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MQA Support Specialist
vor 1 Monat
Friedberg, Hessen, Deutschland FRESENIUS_KABI VollzeitAbout the RoleAt FRESENIUS KABI, we are dedicated to excellence in the pharmaceutical industry. Our commitment spans over two decades, making our facilities pivotal in global production. We are looking for individuals who are eager to contribute their expertise and ideas to our dynamic environment.Key Responsibilities:Facilitate and assist the Validation...
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