Skip to main content

Search Our Jobs

Search with LinkedIn Profile

Small Molecule & Oncology Complaints Specialist

Dublin, Ireland

Overview

Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

Back to Job Navigation (Overview)

Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Agile
  • Ambitious
  • Analytical
  • Collaborative
  • Enthusiastic
  • Entrepreneurial

Back to Job Navigation (Success)

Opportunity

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

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

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

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

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.

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

Back to Job Navigation (Rewards)

Small Molecule & Oncology Complaints Specialist

Apply Now
Job ID SR0043900 Date posted 12/03/2019 Location Dublin, Ireland

Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as our Biologics & Plasma Complaints Specialist.

As our successful Biologics & Plasma Complaints Specialist, you will be responsible for managing the complaints mailbox and input sources and writing product quality complaints and all related activities associated with the complaint handling program at Takeda, per corporate procedure and regulatory standards including goal setting in-line with corporate strategy and priorities and the GQ road map.

The scope of your responsibility will encompass timely management of the complaint processes to comply with corporate procedures, EU and FDA regulations, ISO13485 and other regulatory requirements as applicable.

You will escalate and participate in resolution of potential product deficiencies for all applicable Takeda products originating from a market complaint.

You will liaise with internal stakeholders, Call Centres and service providers to ensure they support Takeda’s corporate policies and guidance while aligning with all the necessary regulations and standards.

You will serve as our Quality liaison between individuals and business units within or outside the organization regarding matters related to product complaint activities, including risk management, regulatory inspections and complaint handling processes for all applicable products.

Key Accountabilities

  • Managing the Complaints Mailbox
  • Serve as point of contact for commercial & clinical product complaints and post market product vigilant monitoring processes
  • Receive, initiate, investigate and conclude product complaint investigations using the current product complaints management software and coordinate all aspects of investigation through closure and/or provide oversight for complaint handling process.
  • Apply departmental procedures to assess product complaints' impact on patient safety and product quality compliance.
  • Assess product complaints and determine if escalation is required due to potential regulatory notification requirements.
  • Interface and collaborate with various departments including the OpUs, External Supply, Quality Assurance, Regulatory, Development, Safety/Pharmacovigilance, etc and the regional organisation. Interface with external stakeholders such as CMO, Call Centres and vendors/contractors on product complaint issues.
  • Assure that all product complaints are investigated to the appropriate level within the required timeline.
  • Send customer response/ mailbox replies.
  • Drive continuous Improvement to ensure a lean and compliant process

Education, Behavioural Competencies  

  • Bachelor's degree with a minimum of 3-6 years of experience in Quality Assurance or a GMP related field.
  • Working knowledge of cGMPs and other regulatory requirements governing combination drugs and device products.
  • Knowledge of EU/ FDA cGMP requirements pertaining to drug/device product complaints reporting and investigation.
  • Combination working experiences in product complaints handling, deviation management, CAPAs, quality compliance investigations, risk management, and cGMP audits.
  • Good understanding of the manufacture of combination products and the linkage to customer complaints.
  • Strong attention to detail, good organizational skills and well-structured.
  • Have a systematic way of working, prioritizing tasks based on risk or critical - seeking effective solutions within the complexity that surrounds product complaints.
  • Excellent troubleshooting and problem-solving skills.
  • Skill in writing investigation summaries and complaint responses.
  • Independent, organized and able to schedule work without supervision to meet schedule deadlines.
  • Ability to work independently as well be an effective team member and leader.
  • Approachable and possess the ability to forge solid working relationships with colleagues across all functions, its partners and contractors.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.



Job ID SR0043900

Apply Now Email Me

Explore the Area

Check out where you could be
working if you apply.

View Map