QA Validation Expert

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

Job description:

Job Description

About the role

Within the Quality Department, reporting to the Head of Quality Systems and Quality Validation, the main propose of this function is to provide support to our amazing QA Validation team on reviewing validation deliverables (validation plan, protocols, reports, URS, design qualification, risk assessment...), and contributing to the implimentation of some exciting projects on our site based in Neuchâtel.
How You Will Contribute

As a Quality Validation Expert for the Quality Department we are looking for someone with strong experience in CSV and DI, with proficiency in QC area and Manufacturing Science Lab topics/equipment.
What You Bring To Takeda

• You will be responsible for quality aspects during the validation activities.
• Provide Validation expertise support related to strategy definition, problems solving, root cause analysis, deviation investigation and implementation steps
• Act as QA validation representative for both validation routine activities and projects.
• Ensure quality of information within validation documentation with respect to current regulations and internal procedures.
• Being responsible for reviewing and approving validation protocols, reports, procedures and other documents related to first CSV, DI then cleaning, sterilization, equipment, process, HVAC, utilities to ensure compliance to internal procedures and regulatory requirements.
• Review and approval of routine monitoring protocols (CIP, SIP, Temperature control unit, computerized systems)
• Define and challenge, with validation teams, validation approaches to be compliant with current regulations
• Act as the QA validation representative in projects: ensure the quality validation aspects are respected within project, raise compliance gaps to the manager
• Evaluate and approve deviations related to validation protocols in order to guarantee proper tracking/documentation of the incidents and identification of corrective actions.
• Responsible for approving investigation and development protocols and reports related to studies and future change controls Validation Strategy definition

Required profile:

Education & Experience & Skills

• Bachelor level degree in life technology fields (i.e. biotechnology, (bio)chemistry, engineering); advanced degree preferred
• 5+ years experience with at least 3 years with cGMP manufacturing, Quality, and Compliance and demonstrated use of Quality tools/methodologies
• Knowledge of a GMP environment
• Knowledge and experience of Bio-Pharmaceutical
• Knowledge and understanding of relevant regulations enabling effective partnerships across the organization
• Multitasks, prioritizes and meets deadlines in timely manner.
• Ability to analyze, review and interpret validation data
• Ability to interact with all types of personalities and teams in an effective and diplomatic manner.
• Critical thinking and demonstrated problem solving / root cause investigation skills
• You have good analytical skills and ability to simplify the complex.
• Good organizational skills and continuous improvement mindset.
• You are autonomous, reactive and flexible.
• You have ability to drive change.

What we offer:

What Takeda Can Offer You

• Attractive salaries
• Full accident cover
• Participation in health insurance premiums
• Advantageous retirement plans
• Subsidized meal
• Financial participation in the sports practices of its employees
• Transportation support in local public transport, free parking, carpooling program
• Takeda Neuchâtel offers to its employees an attractive framework and working conditions. The well-being, safety, development and career development of its employees are at the heart of our vision and of our Human Resources, Health, Environment and Safety policies.
• Takeda Neuchâtel is an employer committed to its employees and future generations.