- To support the quality control processes for the small molecules laboratories in the following activities related to analytical method transfer (AMT); AMT Protocol review. Analytical testing and execution of transfer protocols. QC batch data review. Transfer report drafting support. Support scheduling of protocol execution/testing. Work directly with method transfer lead. Support Laboratory Investigation Record (OOS/OOT) and general Deviation/CAPA completion. QC SOP and 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, and train other QC analysts where required.
- To ensure all laboratory equipment is maintained and calibrated as required.
- To support lab scheduling and support laboratory testing by exception, where required.
- To support development of required documents, including SOPs, specifications, and forms for QC systems and processes, in conjunction with QC Executive \ Site Quality Control Head or designees.
- 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 supporting external audits (HPRA, FDA, corporate, client).
- Ensure data integrity guidelines are implemented and adhered to for QC based systems.
- 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.
- Minimum of a BSc Degree (life science).
- Practical experience working in a GMP QC Laboratory (minimum 2 years).
- Previous experience with testing of small molecule Drug Product or API general techniques is required, e.g. Dissolution, Assay/Impurities by HPLC/GC, Moisture content by Karl Fischer, and general wet chemistry techniques etc.
- Experience with Small Molecule Analytical Method Transfers, specifically with HPLC/GC methods, would be advantageous.
- Experience with reviewing and writing SOP's and transfer/validation protocols and reports would be advantageous.
- Previous experience with Empower would be advantageous.
- Good project management.
- Good time management.
- Good Motivation and Ability to work on own initiative is required.
- 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
- Flexible employee funded options like Dental Insurance, Partner Life Insurance, Serious Illness Protection, Fuel Card, Bike to Work, Commuter Ticket, and Insurance Deals
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QC Analyst - County Tipperary, Ireland - Takeda
Description
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 Analyst.
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 :
General Responsibilities:
What you bring to Takeda :
What Takeda can offer you:
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 wasestablished 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, IrelandWorker Type
EmployeeWorker Sub-Type
Fixed Term (Fixed Term)Time Type
Full time
