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Job Description

Job title: QC Analyst, Small Molecules

Location: Ireland, Grange Castle

JOB PURPOSE:

To support all Laboratory Quality Control activities related to the analytical method transfer in support of New Product Introductions (NPI) and to assure compliance with applicable regulations as well as company policies and procedures at Grange Castle Small Molecules facilities.

RESPONSIBILITIES:

• 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.

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.

EDUCATIONAL REQUIREMENTS:  

• Minimum of a BSc Degree (life science).
• Practical experience working in a GMP QC Laboratory (minimum 2 years).

RELEVANT EXPERIENCE:

• 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.

SKILLS/COMPETENCIES:

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

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.

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