Quality Assurance Manager (m/f/d) at Helm Agro
Luckenwalde, Brandenburg, Germany -
Full Time


Start Date

Immediate

Expiry Date

21 Feb, 26

Salary

0.0

Posted On

23 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Quality Assurance, Pharmaceutical Quality Management, Document Control, Training Management, Customer Audits, Regulatory Inspections, Quality-Related Complaints, Communication Skills, Organizational Skills, Technical Understanding, Initiative, German Language Skills, English Language Skills, Computer Skills

Industry

Chemical Manufacturing

Description
Position Objective: Participation and independent fulfillment of tasks in quality assurance according to AMWHV / EU-GMP guidelines Responsibilities: Implementation of requirements formulated in relevant EU regulations for quality management Handling tasks to maintain and monitor the pharmaceutical quality management system Promoting quality awareness within the company Participation in document control by creating or reviewing quality-relevant documents Processing deviations and changes Participation in training management Participation and support in conducting customer audits and regulatory inspections Participation in the investigation and resolution of quality-related complaints Collaboration in overarching, cross-departmental projects, as needed Interface communication with other department Your Profile: Successfully completed university studies in pharmacy, veterinary medicine, natural sciences, or similar Several years of relevant work experience in quality assurance, production, or quality control of a GxP-regulated pharmaceutical company or a similarly regulated company (e.g., medical device manufacturer) Solid experience in quality management systems (e.g., EU-GxP, DIN ISO standards 9001 or 13485) Strong technical understanding of pharmaceutical processes and business processes Organizational and communication skills, as well as a sense of responsibility Structured and goal-oriented action Hands-on mentality with a high level of initiative Strong communication skills and assertiveness Very good German and English language skills in speech and writing Good computer skills

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Responsibilities
The Quality Assurance Manager will implement EU regulations for quality management and maintain the pharmaceutical quality management system. They will also promote quality awareness and participate in document control, training management, and customer audits.
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