Quality On The Shop Floor Specialist
3 settimane fa
Location: Pisa, Italy
Takeda is seeking a Quality On The Shop Floor Specialist to ensure the execution of production processes for the manufacturing of sterile products follows cGMP/Annex 1 regulations and internal/global procedures.
Key Responsibilities:
* Promote the application of good manufacturing practices in aseptic behavior and ensure training and oversight of aseptic process activities.
* Ensure compliance with regulatory requirements and develop/maintain standard operating procedures (SOPs) for sterile processes.
* Provide technical oversight to ensure aseptic processing aligns with international standards.
* Support the definition and implementation of contamination control strategies (CCS) and promote continuous improvement in aseptic technique culture/behavior.
Requirements:
* Bachelor's degree in microbiology, biology, or biochemistry.
* Minimum of 3+ years of experience in quality assurance or a similar role in a pharmaceutical manufacturing environment.
* Knowledge of current regulatory requirements for Aseptic manufacturing that use RABs and isolator technologies and cGMP /Annex 1.
* Experience in investigations and data analysis, with problem-solving aptitude.
About Us:
Takeda is a patient-focused company that inspires and empowers employees to grow through life-changing work. We foster an inclusive, collaborative workplace where our teams are united by an unwavering commitment to deliver better health and a brighter future to people around the world.
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