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About the role:
To work within the Quality Assurance Department to help maintain quality standards throughout the company. The brief requires a thorough knowledge of Good Manufacturing Practice, current FDA & EMEA regulations for solid oral dosage pharmaceuticals for human use and a good working knowledge of manufacturing processes and packaging processes used in the pharmaceutical industry.
Please note this is fully onsite work mode.
How you will contribute:
Quality Review of Batch Records
To assist in the investigation into non-conformances, participate in root cause analysis and carry out quality review of non-conformances
Preparation and revision of cGMP documentation, Annual Product Reviews, Standard Operating Procedures, Product specification etc. within the QA Department as required.
Support the site Quality Management systems including; the Deviation and CAPA Management systems, Change Control system, Internal Auditing programs, GMP Training, Customer Complaints and the Vendor Management program.
Participate in and facilitate continuous improvement projects as required
Member of the Self-Inspection Audit Team
Control/storage of retain samples, including periodic retain inspection
Presenting GMP Training to Takeda employees
Drive and promote the corporate values of Takeda-ism within the workplace
Other duties as required and assigned from time to time by the Senior Director, Quality or any other officer appointed by the Board of Directors
Drive and promote the corporate values of Takeda-ism within the workplace
Participate fully in any cross functional training initiatives.
Participate in Quality on shop floor Global initiative
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 TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business. 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 Manager, QA or other Officer appointed by the Board of Directors.
What you bring to Takeda:
Relevant third level qualification in a Science discipline.
Minimum 2 years pharmaceutical experience
Excellent verbal and written communication skills
Be a self-starter who is motivated and innovative
Strong interpersonal and Communication skills
Good organizational skills.
What Takeda can offer you:
Full Healthcare Cover – includes dependents
Pension Scheme
Attractive Bonus
Subsidised canteen
Parking facilities with electric car charging points
Health & Wellness programs including onsite flu shots and health screenings
Educational Assistance
Important Considerations
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
Work in a cold, wet environment.
Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
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.
Bray, Ireland
Employee
Fixed Term (Fixed Term)
Full time
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