Sterility Assurance Lead

**Job Title: Sterility Assurance Lead**:
**Location: Pisa**:
**The Sterility Assurance Lead will ensure that the production processes for the manufacturing of sterile products are executed following cGMP/Annex 1 regulations and in adherence to the internal and global procedures. The Sterility Assurance Lead must have strong expertise in aseptic practices and processes that use RABs and isolator technologies. Experience in conducting aseptic process simulations is demanded.**:
**Key Responsibilities of Sterility Assurance Lead are the following**:
- ** Ensuring that aseptic processing aligns with international standards by providing technical oversight and sterility assurance expertise.**:
- ** Support the development of sterilization processes for products manufactured by the site.**:
- ** Define and approve environmental monitoring program and analyze data by trend analysis, to ensure that all products meet the required sterility and prevents issues that may impact product sterility.**:
- ** Ensure compliance with regulatory requirements; develop and maintain standard operating procedures (SOPs) for sterile process.**:
- ** Lead the definition and implementation of the appropriate contamination control strategies (CCS) and promote the continuous improvement in aseptic technique culture/behavior.**:
- ** Conduct risk assessments and develop mitigation strategies to minimize the risk of contamination, identifying potential sources of contamination and developing strategies to mitigate the risk.**:
- ** Collaborate with cross-functional teams to ensure that all products are manufactured in compliance with sterility requirements.**:
- ** Define the strategy for Aseptic Process Simulation validation/revalidation activities.**:
- ** Manage a team, provide guidance and support as needed to ensure that all team members are trained in sterilization processes and procedures.**:
- ** Provide training to employees on sterilization processes, GMP/Annex 1 requirements and procedures. ensuring that all employees are trained in the appropriate processes and procedures.**:
- ** Participate in audits and inspections to ensure compliance with regulatory requirements.**:
- ** Provide technical support and Subject Matter Expert inputs for manufacturing-related process improvements, change control, deviation investigation, and CAPA implementation.**:
- ** Collaborate at global level to harmonize the practices/procedures/processes between the various sites across the network.***:
**Qualifications**:
- ** Bachelor's degree in a relevant field such as microbiology, biology, or biochemistry**:
- ** Minimum of 5+ years of experience in a sterility assurance role in a pharmaceutical manufacturing environment. In-depth knowledge of current regulatory requirements for Aseptic manufacturing that use RABs and isolator technologies and cGMP /Annex 1**:
- ** Leadership skills: communication, decision-making, strategic thinking are required skills**:
- ** Experience in investigations and data analysis, with robust aptitude for problem solving; strong knowledge of Aseptic manufacturing process and related microbiological aspect**:
- ** Experience in data analysis and statistic**:
- ** Strong communication and interpersonal skills to collaborate with cross-functional teams and provide training to employees, strong leadership, and organizational skills.**:
- ** Attention to detail and be able to work in a dynamic environment to ensure that all products are manufactured in compliance with sterility requirements.**:
- ** Experience working with regulatory bodies and hosting regulatory inspections.**:
**More about us**:
**At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.**:
**Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.**:
**Empowering our people to shine**:
**Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.**:
**Locations**:
ITA - Pisa
**Worker Type**:
Employee
**Worker Sub-Type**:
Regular
**Time Type**:
Full time