Location: Luckenwalde
Start Date: 01/04/2025
Working hours: Full-time (39.75 hours/week)
Business Area: Production
"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. We are seeking an ambitious colleague to join our team as a Shift Production Manager.
Position Objective:
To lead the respective production shift in the manufacturing of pharmaceutical active ingredients in accordance with legal requirements, particularly those of the AMG, AMWHV, EG-GMP guidelines, and other relevant national/international standards.
Responsibilities:
- Provide technical leadership and development of the team
- Review all batch manufacturing records and ensure they are fully completed and signed
- Ensure that all production deviations are recorded and reported, and that critical deviations are addressed and investigated with appropriate conclusions drawn
- Ensure that production facilities are in a GMP-compliant state
- Conduct qualifications of new and, if necessary, modified facilities and equipment, and verify correctness
- Lead, plan, and coordinate shift workers, ensuring smooth holiday planning
- Participate in internal audits and inspections as well as customer and regulatory inspections
- Contribute to overarching, cross-functional projects as needed
- Interface communication with other departments
- Work in shift and weekend duty (early/late/night/holidays)
Your Profile:
- Successfully completed technician or master examination or training as a chemical and pharmaceutical technologist (CTA, PTA) or comparable education, ideally from a similar industry or with a focus on PLS controls
- Strong technical understanding of production processes and production equipment
- Proficient in operating PLS (PCS7)
- Knowledge of working in a GMP environment
- Willingness to work in shifts and weekends (early/late/night/holidays)
- Organizational and communication skills, as well as sense of responsibility
- Structured and goal-oriented action
- Ability to adapt to rapidly changing environments and circumstances
- Experience with activities in clean rooms is advantageous
- Knowledge of SAP is desirable
"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.