Quality Control Analyst

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Job Description

Job title: Quality Control Analyst

Location: IRL - Bray

JOB PURPOSE:

The brief requires a thorough knowledge of Good Manufacturing Practice, current FDA & EMEA regulations for solid oral dosage pharmaceuticals for human use and a good working knowledge of manufacturing processes, packaging processes and validation activities used in the pharmaceutical industry. This brief also demands a commitment to the quality effort and the application of good analytical and technical skills

RESPONSIBILITIES:

• To observe GLP/cGMP at all times
• Testing of all laboratory samples including Raw Materials, Packaging Components, Product, Validation, Stability, Environmental, OH
• Performance of laboratory tests as per written procedure or as per pharmacopoeia
• Recording of analytical results accurately
• Operation, maintenance and calibration of laboratory instruments
• Preparation and execution of instrument and method validation protocols
• To maintain written training records
• To ensure that the laboratory is kept clean, tidy and safe at all times
• To report any non-conformance, instrument malfunction, accident or other abnormal occurrence to immediate superior
• Ordering, receiving and controlling laboratory chemicals, reagents and consumables.
• Receiving and controlling test samples.

GENERAL RESPONSIBILITIES:

• 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 Manager, QC or other Officer appointed by the Board of Directors.

EDUCATIONAL REQUIREMENTS:  

• BSc. (minimum) in science or a related discipline.

RELEVANT EXPERIENCE

• Have relevant experience in the pharmaceutical industry.
• Have a minimum of 2-3 years experience in an analytical lab.

SKILLS/COMPETENCIES

• Have good organisational, communication, interpersonal and report writing skills.
• Is adaptable to changing priorities.

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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