POSITION: CLEANING VALIDATION SPECIALIST
ABOUT THE ROLE:
• Support and execute validation activities related to equipment cleaning procedures.
• Develop and execute validation documents as appropriate in compliance with main internal and external guidelines and policies.
HOW YOU WILL CONTRIBUTE:
Writes I reviews cleaning validation Protocols
• Writes / reviews cleaning validation Final Reports
• Writes I reviews cleaning validation Risk Assessments
• Performs trainings related to cleaning validation activities
• Participates in the execution or supervises the execution of the validation protocols
• Collaborates with production for the drafting of cleaning procedures and the
management I scheduling of validation activities.
• Collaborates with QC for analysis planning, management and flow of samples as part of cleaning validation studies.
Supports the maintenance of GMP archive through correct management of data collection, document consultation, retrieval, return and archiving
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
Experience related to:
• Execution and coordination of assigned Validations related to cleaning procedures of product contact equipment.
• Knowledge of the main quality systems (documentation, audit, change control, training)
Ability to work alone and in team, have good and direct communication skills
Ability to Coordinate resources for some specific task/activity.
• Be Positive
• Be Responsible
• Be results oriented
Decision-making and Autonomy
• Ability to perform Routine Tasks with limited Supervision
• Ability to represent department in meetings for assigned topics
Be able to manage relationships:
• Internal relationship: Production, Engineering, Quality, QC Quality validation,
• External relationship: Suppliers for external consultants services Innovation
• Provide Input for Changes, Issues resolution
• May support other sites by sharing know how
• Definition of validation strategies, identification of the appropriate criteria to be adopted in qualifying and evaluation of the results obtained.
• Management of validation documentation
WHAT YOU BRING TO TAKEDA:
EDUCA TION, BEHA VIOURAL COMPETENCIES AND SKILLS
• Degree in Engineering, Chemistry, Life Science, or other job related discipline + At least 1 years of previous experience in this role or equivalent within pharmaceutical, biotechnology, or related industry, familiar with Quality Management and GxP
• Fluent English (written and spoken);
• Analytical skills with systematic approaches to problem solving.
• Familiar with Quality Management and GxP Regulations
• Proficiency in Microsoft Office
• May require some travel (<5%).
• Flexibility for early or late teleconferences or audits.