Validation Specialist (FTC 12 Months)

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Job Description

Position profile:

The Validation Specialist role is a Fixed Term Contract (FTC) position to support a new API product introduction project on the site at Grange Castle. The successful candidate must be capable of working both on their own initiative and as part of a very flexible team in a demanding, regulated environment. They are required to proactively contribute to the delivery of targets within quality, safety and environmental requirements and on schedule.

Key tasks and Responsibilities

Technology Transfer

Play a leadership role in the introduction of a new process together with the preparation and execution of process validation programs.

Be the Subject Matter Expert in validation aspects of the process including assessment of critical parameters, implementation of control strategies and definition of cleaning program.

Support cleaning and process risk assessment programs to define validation and cleaning approach.

Preparation and execution of plans, protocols and reports associated with process validation and cleaning validation ensuring compliance with current industry regulations.

Quality Systems and GMP

Perform operations in accordance with TILGC quality standards, current Good Manufacturing Practices (cGMP) and all other relevant policies, procedures, regulations and standards including Health & Safety and Environmental (HSE) Legislation.

Complete required documentation in an accurate and timely manner. Such documentation would include (but not be limited to) records required by SOPs, Logbooks and Labels as well as HSE records.

Generate documentation associated with their activities as required by cGMP and review Standard Operating Procedures (SOPs), Batch Manufacturing Instruction and Record (BMRs), Logbooks, Labels, In-Process Test documentation, and other regulatory documentation (Quality, Health & Safety, Environmental) as required.

Safety & Environment

Actively foster, in cooperation with other TILGC staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business.

Adhere fully to all safety policies, procedures and regulations.

Notify the relevant Manager (or other appropriate responsible person) in a timely and comprehensive manner of any breach of HSE policy, procedure or regulation.

Training

Actively participate in all training and assessment activities (internal and external) in relation to themselves, manufacturing personnel or other employees.

Ensure timely completion of all SOP training and assessment tasks.

Ensure that all training and assessment is accurately and promptly recorded for themselves and other relevant personnel in accordance with TILGC procedures.

EDUCATIONAL REQUIREMENTS: 

Primary degree in a scientific discipline

RELEVANT EXPERIENCE:

Experience of supporting an API Technology Transfer.

3-5 years experience of working in a validation role in a regulated environment.

Excellent knowledge of validation regulations and guidelines.

A strong technical understanding of processes and equipment.

SKILLS AND COMPETENCIES:

Excellent verbal and written communication skills

Be self-motivated, flexible, organised and a good team player with the ability to prioritise own work based on departmental and site requirements.

What you can look forward to with us:

• Competitive Salary: Including performance-based bonuses.

• Retirement Plan: Employer contributions to your retirement plan.

• Comprehensive Insurance: Employer-funded private medical insurance with dependants’ cover, life insurance, and flexible options like dental insurance, partner life insurance, and serious illness protection.

• Electric Charging Points: Available at parking locations.

• Employee Assistance Program: Support for personal and professional challenges.

• Wellbeing and Engagement: Dedicated teams to support your wellbeing.

• Family-Friendly Policies: Supportive policies for a balanced work-life.

• Generous Vacation: 26 vacation days plus additional days for service milestones and humanitarian volunteering leave.

• Development Opportunities: Coaching, mentoring, educational programs, and formal training.

• Subsidized Canteen: Enjoy meals at a reduced cost.

• Flexible Benefits: Options like fuel card, bike to work, commuter ticket, and insurance deals.

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.

If you are interested in this opportunity, we look forward to receiving your application via our online tool!

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