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Quality Control Team Leader (FTC 14 months)

Wicklow, Leinster
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At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you’re a part of our team, you’ll do meaningful work that makes an impact on the lives of patients. Learn more about us and explore the opportunities to build a remarkable career.

Job ID R0137807 Date posted 11/07/2024 Location Wicklow, Leinster

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Job Description

JOB PURPOSE:

To work within the Quality Control Department for 14 months (maternity cover) to help maintain quality standards throughout the company. 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 and packaging processes used in the pharmaceutical industry.

RESPONSIBILITIES:

  • Ensure that the QC lab is in compliance with Good Laboratory Practice/Good Manufacturing Practice. Implement and maintain standards of GLP practice consistent with regulatory expectation and cGMP.
  • Responsible for all aspects of guidance of a team of QC analysts/technicians, including performance management and the execution of business processes to a high standard as monitored.
  • Support your team and help them to perform to a high standard, in the achievement of the company and department goals.
  • Inspire enthusiasm and stimulate interest and guiding staff to ensure they are productive.
  • Safety, cGMP and Continuous Improvement.
  • Ensure that Production, QA, Planning, Shipping and support departments receive an quality service through meeting scheduled target release dates and compliance standards.
  • Training, recruitment, discipline and performing appraisals of QC analysts/technicians.
  • To perform an investigation into any non-conformance, instrument malfunction, accident or other abnormal occurrence.
  • Validation, operation, maintenance, calibration and trouble shooting of laboratory instruments.
  • Approval of relevant QC documentation
  • Support major Projects, quality plans and continuous improvement programmes within the department and in other.
  • Prepare for and supporting external audits (HPRA, FDA, corporate, or client).
  • Implement and maintain standards of safety to guarantee a safe working laboratory. Ensure that the laboratory is kept clean, tidy and safe.
  • To highlight and implement new technologies in QC area.
  • To maintain the validated status of the LIMS/Empower systems and other relevant systems and to manage them to assure compliance with acceptable regulations and company policies.
  • Support of Annual Product Reviews
  • To act as designee for Manager; QC Laboratory in their absence.

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

EDUCATIONAL REQUIREMENTS:  

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

RELEVANT EXPERIENCE:

  • 5 years experience in an analytical lab preferably with supervisory responsibilities.
  • Technical experience of GC / HPLC Analysis required.
  • Experience with continuous improvement plans within the QC environment.
  • Experience managing, motivating and leading a team of analysts

SKILLS/COMPETENCIES:

  • Promote teamwork by promoting a supportive and inclusive team atmosphere and to focus people on priorities and guide them to achieve their goals
  • Address performance issues and establish specific plans to help team members reach goals
  • Provide team members with, constructive feedback, coaching and support to help them recognize and on their strengths and development needs.
  • Good investigational and technical writing skills.
  • Be a self starter who is willing to learn.
  • Strong Interpersonal & communication skills.
  • Problem solving capability.
  • Good organisational skills.

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.

Locations

Bray, Ireland

Worker Type

Employee

Worker Sub-Type

Fixed Term (Fixed Term)

Time Type

Full time
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Working at Takeda

  • Inclusion

    Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.
  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.
  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

  • Integrity

  • Fairness

  • Honesty

  • Perseverance

We're Steadfast In Our Commitment to Four Key Imperatives

Patient


Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.

People


Create an exceptional people experience.

Planet


Protect our planet.

Data & Digital


Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.

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About our location

Wicklow, Leinster


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