Scientist, Facility Compliance - #335754
The team comprise of seven engaged colleagues (you being the seventh) and one team leader that are driven by the ever-changing manufacturing pace. We strive to ensure a high quality mindset and enjoy a great team spirit.
The team operates under cGMP and are responsible for continuous facility compliance of our mammalian, microbial and adjuvant lines. With the establishment of a new facility the Facility Compliance will look into even more responsibility to ensure alignment across the 2 production facilities.
The team is responsible for securing the compliance framework with regards to cleanroom facility compliance and environmental monitoring with emphasis on SOP´s, training documentation, deviations and CAPA management.The position As a scientist in the Facility Compliance team, you will become a specialist in the whole portfolio of task related to facility compliance and environmental monitoring. You will be regarded as a role model and will also be responsible for:
- Owners of and responsible for continuously improving the procedures for gowning, aseptic behavior and Flow and Logistic.
- Process confirmations of above procedures
- Evaluation of current and new cleaning procedures
- Support to the manufacturing teams with tasks related to facility compliance handling deviations
- Training of manufacturing associates
- Handling CAPA's related to deviations
- Handling changes related to facility compliance and EM processes
- Participate in regulatory inspections and audits
- Participate in board meetings, KPI delivery and follow-up
- Optimization and standardization of work processes related to facility compliance
- 3+ years of experience from the pharmaceutical industry working in an cGMP environment
- Strong communicator
- A natural role model and coach for improving aseptic behavior
- Structured and analytically oriented
- Experience with applied Lean
- A genuine interest in being close to the manufacturing floor and understanding the need for process confirmation
As a person you are driven by continuously improving processes and procedures. You are curious, have a good overview, is eager to learn and value being a team player. You thrive in a high pace environment where no two days are the same.
For further information, please contact Yasin Senel, Team Leader, Facility Compliance, phone +45 22943093.
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AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company's team and approach are tailored to each of its client's needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.
Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.