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Job DescriptionJob Purpose:
Support all Laboratory Quality Control activities related to analytical method transfers in support of New Product Introductions (NPI) while ensuring compliance with regulations, company policies, and procedures at Grange Castle Small Molecules facilities.
Responsibilities
Support quality control activities related to analytical method transfers (AMT), including:Reviewing AMT protocolsExecuting analytical testing and transfer protocolsReviewing QC batch dataAssisting with drafting transfer reportsScheduling protocol execution and testingCollaborate closely with the method transfer lead.Support investigations for out-of-specification (OOS) and out-of-trend (OOT) results and assist in completing Deviations and CAPAs.Draft, update, and review QC SOPs and test methods.Provide laboratory systems support and troubleshoot issues.Maintain and calibrate laboratory equipment as required.Assist with lab scheduling and support exceptional laboratory testing.Develop and maintain documentation for QC systems (SOPs, specifications, forms) in collaboration with QC leadership.Liaise with QC, QA, IT, and Manufacturing Operations to ensure compliance and smooth workflows.Conduct investigations into non-conformances, accidents, and other irregularities.Maintain and promote high safety standards within the laboratory.Identify and implement new technologies in QC.Prepare for and support external audits (HPRA, FDA, corporate, client).Ensure data integrity compliance for all QC systems.Participate in cross-functional training initiatives and actively promote Takeda’s corporate values ("Takeda-ism").Complete accident/near-miss reports and all required training and assessments on time.Perform additional duties as assigned by management.What You Can Bring to Takeda
A minimum of a BSc degree in life sciences.At least 2 years of practical experience in a GMP QC laboratory environment.Hands-on experience with small molecule drug product or API testing methods, including:Dissolution testingAssay and impurities analysis via HPLC/GCMoisture analysis using Karl Fischer titrationGeneral wet chemistry techniquesExperience with analytical method transfers, especially HPLC/GC methods, is advantageous.Proven ability to review and write SOPs, transfer/validation protocols, and reports.Strong understanding of GMP requirements and compliance.Ability to troubleshoot laboratory systems and contribute to continuous improvement.Commitment to maintaining a safe working environment and promoting safety culture.Effective communication and teamwork skills to liaise across departments.What you can look forward to with us:
Competitive Salary: Including performance-based bonuses.Retirement Plan: Employer contributions to your retirement plan.Comprehensive Insurance: Employer-funded private medical insurance with dependants’ cover, life insurance, and flexible options like dental insurance, partner life insurance, and serious illness protection.Electric Charging Points: Available at parking locations.Employee Assistance Program: Support for personal and professional challenges.Wellbeing and Engagement: Dedicated teams to support your wellbeing.Family-Friendly Policies: Supportive policies for a balanced work-life.Generous Vacation: 26 vacation days plus additional days for service milestones and humanitarian volunteering leave.Development Opportunities: Coaching, mentoring, educational programs, and formal training.Subsidized Canteen: Enjoy meals at a reduced cost.Flexible Benefits: Options like fuel card, bike to work, commuter ticket, and insurance deals.
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.
If you are interested in this opportunity, we look forward to receiving your application via our online tool!