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Job Description

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 a key 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 in support of the method transfers for NPI.

• To ensure all laboratory equipment is maintained and calibrated as required.

• To support lab scheduling and support laboratory testing by exception, where required.

• To develop and maintain required documents, including SOPs, specifications, and forms for QC systems and processes, in conjunction with QC Executive \ Site Quality Control Head or designees.

• Support Pharmacopeial reviews and raw material incoming inspection testing specification justifications.

• To deliver training as appropriate to QC personnel.

• To liaise with QC, QA, IT and Manufacturing Operations departments in the performance of normal duties and end user compliance across all areas.

• To carry out the investigation into any non-conformance, accident or other abnormal occurrence

• Maintain standards of safety to ensure a safe working laboratory.

• To highlight and where necessary implement new technologies in QC area.

• Preparing for and support external audits (HPRA, FDA, corporate, client).

• Ensure data integrity guidelines are implemented and adhered to for QC based systems.

General Responsibilities:

• 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).

• Practical experience working in a GMP QC Department (minimum 6 years).

• Experience with Small Molecule Analytical Method Transfers, specifically with HPLC/GC methods

• Experience with 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 with 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.

• Good time management.

• Good Motivation and Ability to work on own initiative is required.

What Takeda can offer you:

• Competitive salary and 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 working arrangements, e.g., hybrid or shiftwork with shift allowance

• Family friendly policies

• 26 vacation days plus additional days for service milestones

• Coaching and mentoring

• Educational programs 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 business areas, 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 innovation. 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, 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 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