Quality Assurance Manager (m/f/d)

HELM AG; Luckenwalde; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A globally recognized pharmaceutical company in Luckenwalde is seeking a Quality Assurance Manager to oversee quality management systems in compliance with EU regulations. The successful candidate will have a strong background in pharmaceutical quality assurance and several years of related experience. Key responsibilities include implementing quality standards, promoting awareness within the company, and maintaining regulatory compliance. Proficiency in German and English is essential. Join a dynamic team dedicated to life-saving products.

Leistungen

Development opportunities

Internal/external training

Work-life balance benefits

Qualifikationen

• Several years of relevant work experience in quality assurance, production, or quality control.
• Solid experience in EU-GxP and ISO standards 9001 or 13485.
• Strong technical understanding of pharmaceutical and business processes.
• Organizational and communication skills.

Aufgaben

• Implement EU regulations for quality management.
• Maintain and monitor pharmaceutical quality management systems.
• Promote quality awareness within the company.
• Participate in document control and compliance tasks.

Kenntnisse

Quality management systems

Pharmaceutical processes

Communication skills

German language skills

English language skills

Ausbildung

University studies in pharmacy, veterinary medicine, or natural sciences

Tools

Computer skills

Jobbeschreibung

Helaxa is a company in Luckenwalde founded in 2022 by Erol Isim and the traditional family business HELM AG and specialises in the production of the life-saving active ingredient heparin. On a total area of 22,500 square metres, the most modern and efficient production facility in Europe is being built, which will meet the highest quality standards.
We are looking for

Quality Assurance Manager (m/f/d)

Date: Dec 19, 2024
Location:
Luckenwalde, DE, 14943
Business Unit: Helaxa GmbH & Co KG
Job Function: Quality Management / HSE
Level of Experience: Executive

"Caring today. Enabling tomorrow" is more than just a slogan for us. It is the daily inspiration for collaboration, as well as all our actions and decisions. This describes the philosophy of Helaxa, a newly established company in Luckenwalde dedicated to manufacturing active ingredients for life‑saving medicine. For our dynamic and growing company in Luckenwalde, we are seeking for dedicated talents (m/f/d) who are motivated to drive our mission ‘Caring today. Enabling tomorrow' with passion.

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

"A new player. A new culture. A new game." Each individual contributes to the success of Helaxa daily through responsible actions, extensive expertise, and unique service. We value this commitment, not only by offering development opportunities and internal/external training but also by providing benefits that create optimal conditions for a work‑life balance. We look forward to meeting you.
Does this sound like you?
Then we look forward to receiving your detailed application via our application portal.