Quality On The Shop Floor Specialist

3 settimane fa


Vicenza, Veneto, Italia Takeda Pharmaceutical A tempo pieno
Job Title: Quality On The Shop Floor Specialist

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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