QC Analyst P2 - Grange Castle
Business Area Overview
On the Global Manufacturing and Supply (GMS) team at Takeda, you’ll be part of a rapidly transforming industry that’s applying technology and data in new ways. Within our agile, innovative, people-centric organization, your work will matter every day as you use your skills to help us manufacture therapies for patients on our four platforms:
- Small Molecules
- Cell and Gene
As part of the GMS team, you'll have the opportunity to pursue unique experiences and build new skills, and you'll know that the work you do every day makes an impact — on our patients, our people, our planet, and on yourself.
Working at Takeda
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Recognized for our culture and way of working, we’re one of only 11 companies to receive Top Global Employer® status for 2022.
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
QC Analyst P2 - Grange CastleJob ID R0069949 Date posted Jun. 21, 2022 Location Dublin, Ireland
About the role:
The QC Analyst has an important role to play in the start up of the TIL GC Quality Control laboratory in a new manufacturing facility and the routine operation of the QC laboratory when start-up is complete. The QC Analyst will have specific and varying duties and some key tasks and responsibilities are outlined below. During start-up flexibility is important and responsibilities may change or other duties may arise.
Fully onsite work mode.
How you will contribute:
Contribute effectively to the design and implementation of quality systems in the QC laboratory to meet the requirements of ICH Q7A.
Work with other QC personnel in the preparation and review of the required documentation in the QC laboratory, including Standard Operating Procedures, Analytical Procedures, Analytical Worksheets and Material Specifications.
Participate, as directed, in the following activities in the QC laboratory:
Reference Standard Management
LIMS data management and maintenance
Lean Laboratory Techniques
Provide expertise in a variety of analytical test procedures.
Carry out sampling and analytical testing of raw materials, packaging materials, intermediates, Drug Substance and Drug Products according to approved TIL GC procedures and plant schedules. Examplesof analytical techniques utilised include; HPLC, GC, Wet Chemistry, IR, UV, Particle Size and Dissolution.
Carry out sampling and testing of manufacturing facility cleaning samples.
Carry out sampling and chemical testing of manufacturing facility pure water samples
Ensure that all testing information is recorded accurately and completely according to TILGC procedures.
Ensure that any deviations or out of specification (OOS) results are reported immediately to the QC Senior/ QC Executive so that corrective action may be taken.
Provide assistance and guidance in deviation investigations, OOS investigations, and change proposals.
Provide samples to contract testing laboratories and liaise with these laboratories as required.
Familiarity with CDS and LIMS is desirable but not essential
Carry out method transfer and method validation work as required, to meet project deadlines.
Review equipment qualification documentation for QC Laboratory equipment.
Participate in the cleaning validation programme at the TIL GC facility.
Good Laboratory Practices:
Ensure that Good Laboratory Practices are followed at all times.
Ask, if in doubt, about any particular practice or unusual finding.
As a member of the quality function, work with other departments to promote a culture of compliance to Good Manufacturing Practice within the plant.
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 relevant Manager or other Officer appointed by the Board of Directors.
What you bring to Takeda:
Minimum of a BSc Degree (life science)
A minimum of 3 years’ work experience in a regulated GMP/GLP environment
Practical experience with HPLC and GC systems
Experience with writing and reviewing SOP’s / validation protocols
Experience with Method transfer / validation, desirable but not essential
Experience working in an DS/DP facility, desirable but not essential
Good time management
Experienced in technical writing
Ability to work on own initiative in an unsupervised manner
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
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.
LocationsGrange Castle, Ireland
Time TypeFull time
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