Job Title: Validation Specialist
Location: Grange Castle
About the role:
Lead manufacturing process and cleaning validation activities in Drug Product, Drug Substance and Packaging operations.
Optional hybrid work model .
How you will contribute:
Co-ordination and oversight of Small Molecule validation activities ensuring compliance with current industry regulations, guidelines and trends. These activities include: process validation, cleaning validation, continued process verification.
Preparation and maintenance of policies and SOPs associated with manufacturing process validation and cleaning validation (small molecule).
Preparation, review and execution of validation plans, protocols/reports and associated deviations.
Participation in cross-functional project teams as the validation representative.
Ensure that processes remain in a state of control through management of the Continued Process Verification program including generation of reports, statistical review of data and implementation of control limits.
Knowledge in the preparation and review of regulatory documents ensuring compliance with current industry regulations.
Review of all TILGC process related change controls for impact on validation.
Participation in TILGC Continuous Improvement programmes.
Participation in other projects as directed by the Process Development Laboratory Manager.
Liaise with production/scheduling departments to assist and advise on the validation of new/existing processes.
Ensure compliance with current industry regulations and guidelines relating to validation.
Participate in cross-functional training, and direct training of validation personnel by maintaining and improving validation SOPs, forms and training manual.
Participate fully in any cross functional training initiatives.
Drive and promote the corporate values of Takeda-ism within the workplace.
Actively foster, in cooperation with other TILGC staff, an ethos and culture of safety awareness. Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
Ensure timely completion of all SOP reading, training and assessment.
Other duties as required and directed by the relevant Manager.
What you bring to Takeda:
Primary degree in a scientific discipline.
Understanding of pharmaceutical solid dosage manufacturing processes.
At least 8 years experience working in a validation role in a regulated environment although relevant experience in a similar role would be considered.
Excellent knowledge of validation regulations and guidelines
A strong technical understanding of processes and equipment.
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 Takeda can offer you:
Full Healthcare Cover – includes dependents
Parking facilities with electric car charging points
Health & Wellness programs including onsite flu shots and health screenings
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.
Grange Castle, Ireland