Description
Job Title: QC Analyst, Small Molecules
Located in Ireland at Grange Castle
Job Purpose:
To support Laboratory Quality Control activities for analytical method transfer in New Product Introductions (NPI) and ensure compliance with regulations and company policies.
Responsibilities:
* Support quality control processes for small molecules laboratories in analytical method transfer activities: protocol review, testing, data review, report drafting, scheduling, and laboratory investigation record completion.
* Become Subject Matter Expert in laboratory operations for method transfers and train other analysts as needed.
* Maintain laboratory equipment calibration and perform troubleshooting.
* Support lab scheduling and testing by exception.
* Develop required documents, including SOPs, specifications, and forms for QC systems and processes.
* Liaise with QC, QA, IT, and Manufacturing Operations departments.
* Investigate non-conformances, accidents, or abnormal occurrences.
* Maintain safety standards and highlight new technologies for QC implementation.
* Prepare for and support external audits.
* Implement data integrity guidelines.
General Responsibilities:
* Participate in cross-functional training initiatives.
* Drive corporate values and promote a culture of safety awareness.
* Foster a safe working environment.
* Complete accident reports and near miss forms.
* Complete all SOPs, reading, training, and assessment on time.
* Perform other duties as required.
Requirements:
* BSc Degree in life science.
* Minimum 2 years of experience in a GMP QC Laboratory.
Experience:
* Testing of small molecule drug product or API general techniques.
* Analytical method transfers for small molecules, specifically HPLC/GC methods.
* Reviewing and writing SOPs and transfer/validation protocols and reports.
* Empower experience.
Skills/Competencies:
* Good project management.
* Good time management.
* Ability to work independently.
About Takeda:
We transform patient care through novel specialty pharmaceuticals and best-in-class patient support programs. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence.
We foster an inclusive, collaborative workplace, united by an unwavering commitment to deliver Better Health and a Brighter Future.
Takeda is committed to creating a diverse workforce and providing equal employment opportunities without regard to protected characteristics.
Grange Castle, Ireland - Full-time Employee