The Quality Control Lead will serve as point of contact for commercial product complaints and post-market product vigilant monitoring processes. Receive, initiate, investigate and conclude product complaint investigations using the current product complaints management mailbox and software.
KEY RESPONSIBILITIES
* Coordinate all aspects of investigation through to 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 letters where required.
* Support the departmental complaint management process through attendance of meetings to ensure on time closure of complaints.
* Support line manager to meet business needs.
* Represent Takeda as the Subject Matter Expert (SME) for the product complaints in your name during Internal, External and Regulatory Body Inspections.
* Drive continuous Improvement to ensure a lean and compliant process.
RELEVANT EXPERIENCE
* Bachelor's degree with a minimum of 5-9 years of experience in Quality Assurance or a GMP related field within Medical device, biotechnology or pharmaceutical manufacturing, or equivalent.
* 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.
SKILLS/COMPETENCIES
* Desirable experiences: 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.
* Has a systematic way of working, prioritizing tasks based on risk or criticality - seeking effective solutions within the complexity that surrounds product complaints.
* Excellent troubleshooting and problem-solving skills.
* Skill in writing investigation summaries or reports 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.
* Positive and Professional attitudes towards work and colleagues.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance and Manufacturing
Industries
Pharmaceutical Manufacturing
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