Cleaning Validation Supervisor

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Job Description

Job Title: CLEANING VALIDATION SUPERVISOR
Location: RIETI – ITALY

ABOUT THE ROLE:

• Supervising internal and external resources who are responsible for conducting cleaning validation of product contact equipment.
• Establishing cleaning validation strategies for manufacturing equipment
• Driving continuous improvement for validation topics

HOW YOU WILL CONTRIBUTE:

Accountabilities:

• lead and direct the development and execution of protocols relating to cleaning validations in compliance with regulatory requirements
• responsible for overall supervision and oversight during execution of validation activities
• support the projects in relation to the new cleaning equipment/processes
• participate in internal and external audits as Subject Matter Expert (SME) for Engineering Services team
• perform investigation of deviations encountered during the execution of validations and provide documentation to support the findings of the investigation
• knowledgeable of current regulatory guidelines and industry standards pertaining to cleaning validation
• assign jobs and monitor progress to ensure that duties are adequately carried out.
• responsible for creation and release of area specific quality relevant validation documents (SOPs, protocols and reports)
• drive process improvement and investigations for system/equipment where the validation is impacted
• report to Site Engineering Services Lead to ensure compliance to cGMPs and division validation standards
• accountable for fulfillment of internal and external guidelines in the cleaning validation area
• Supports the maintenance of GMP archive through the correct management of consultation, data collection, retrieval, return and archiving.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Expertise in the validation /control of biotechnological or pharmaceutical manufacturing processes
• Comprehensive knowledge and understanding of quality management and GxP principles and uncompromised dedication to quality

Leadership

• Demonstrated people management and supervisory skills
• Strong written and verbal communication skills
• Ability to support cultural changes
• Results oriented
• Reward achievement calling out people who make contributions to the organization.
• Encourage innovation looking at issues from different perspectives
• Sets clear strategic direction
• Creates a working environment that motivates high individual performance
• Focuses on the few priorities and delivers superior results

Decision-making and Autonomy

• Analytical skills with systematic approaches to problem solving

• Ability to represent department in meetings for assigned topics

Interaction

• Internal relationship : Production , Engineering, Quality, QC Quality validation, Manufacturing science
• External relationship: Suppliers for external consultants services, Global validation

Innovation

• Orientation for continuous improving

• Results oriented

Complexity

• Provide Input for Changes, Issues resolution specifically for technical failure analysis on routine/projects processes
• May support other sites by sharing know how
• May support/lead global initiatives implementation

WHAT YOU BRING TO TAKEDA:

• Degree in Engineering, Chemistry, Life Science, or other job related discipline
• Solid leadership experience
• Professional experience in pharmaceutical industry environment of an internationally operating company
• Consolidated experience in cleaning validation
• Experience in dealing with major authorities (FDA, EMA, etc.)
• Experience in the management of medium and large scale projects of advantage
• Fluent English (written and spoken)
• Proficiency in Microsoft Office

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 – Rieti

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time #J-18808-Ljbffr