Small Molecule & Oncology Complaints Specialist
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Small Molecule & Oncology Complaints SpecialistApply Now
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.
- 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