Job Information
Takeda Pharmaceuticals QC Senior Analyst in Dublin, Ireland
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Job Description
QC Senior Analyst
Are you looking for a patient-oriented, innovation-driven company that inspires you and promotes your career? Then take your future in your hands and become part of Takeda as a QC Senior Analyst for 18 months.
Takeda's presence in Ireland was established in 1997 and our Irish operations have played an important role in our global leadership in rare diseases, oncology and gastroenterology. Since beginning commercial operations, Takeda Ireland has grown in strength thanks to substantial investment in our people and industry-leading technology.
How you will contribute:
To support the quality control processes for the small molecules laboratories in the following activities related to analytical method transfer (AMT);
Analytical Method validation review and gap assessments
AMT Protocol writing
QC batch data review
Transfer report writing
Support scheduling of protocol execution/testing
Work directly with and support method transfer testing QC analysts
Laboratory Investigation Record (OOS/OOT) and general Deviation/CAPA completion
QC SOP/Test Method drafting/update/review
General laboratory systems support and troubleshooting
Become Subject Matter Expert (SME) in a range of laboratory operations to support the method transfers for NPI.
To ensure all laboratory equipment is maintained and calibrated.
To support lab scheduling and support laboratory testing by exception, where required.
To develop required documents, including SOPs, specifications, and forms for QC systems, with QC Executive \ Site Quality Control Head or designees.
Support Pharmacopeial reviews and raw material incoming inspection testing specification justifications.
To deliver training to QC personnel.
To collaborate with QC, QA, IT and Manufacturing Operations departments in the performance of normal tasks and end-user compliance across all areas.
To manage the investigation into any non-conformance, accident or other abnormal occurrence
Maintain standards of safety to guarantee a safe working laboratory.
To highlight and implement new technologies in QC area.
Prepare for and support external audits (HPRA, FDA, corporate, or client).
Ensure data integrity guidelines are implemented and observed for QC-based systems.
General Responsibilities:
Participate in any training programmes.
Promote the corporate values of Takeda-ism within the workplace.
Foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an necessary part of the business.
Ensure that Accident Reports / Near Miss Forms are completed promptly after an event.
Ensure timely completion of all SOP, reading, training and assessment.
Other tasks 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).
Practical experience working in a GMP QC Department (minimum 6 years).
Experience with Small Molecule Analytical Method Transfers, specifically with HPLC/GC methods
Experience supporting regulatory audits and knowledge of expectations.
Experience with reviewing and writing SOP's / transfer / validation protocols and reports.
Experienced in technical writing.
Previous experience both Drug Product and API would be advantageous (Dissolution, Assay with HPLC/GC, and general wet chemistry methods)
Previous experience with Empower would be advantageous.
Good project management.
What Takeda can offer you:
Performance-based bonus
Employer retirement plan contributions
Employee Stock Purchase Plan
Revenue approved profit share scheme
Employer funded income protection
Employer funded private medical insurance with dependants' cover
Employer life insurance contributions
Electric charging points available at parking locations
Employee Assistance Program
Wellbeing and engagement teams
Takeda Resource Groups
Flexible time-off, e.g., hybrid or shiftwork with shift allowance
Family friendly policies
26 vacation days plus additional days for service milestones
Educational programmes and formal training
Development opportunities
Humanitarian volunteering leave options
Subsidized canteen (only for Bray and Grange Castle)
Flexible employee funded options like Dental Insurance, Partner Life Insurance, Serious Illness Protection, Fuel Card, Bike to Work, Commuter Ticket, and Insurance Deals
More about us:
Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines.
Takeda Ireland was established in 1997. Our story in Ireland is one of substantial growth, rapid change, and. Over the past two years, Takeda Ireland has invested over €55 million in Ireland to develop our manufacturing sites. Solidifying our commitment in our people and contributing to the local economy. Takeda in Ireland has commercial operations, corporate services, and manufacturing facilities across four locations: Baggot St, Bray, Citywest, and Grange Castle. We have been certified as Top Employer for several consecutive years.
How we will support you:
Takeda is proud of its commitment to create a diverse workforce and to provide equal employment opportunities to all employees and applicants for employment without regard to ethnicity, colour, 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 living with disabilities, chronic illness, or neurodiversity, please feel free to let us know so that we can provide you with appropriate support during the application process.
Locations
Grange Castle, Ireland
Worker Type
Employee
Worker Sub-Type
Fixed Term (Fixed Term)
Time Type
Full time
Takeda Pharmaceuticals
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