Do you relish the opportunity to work with a leading Irish based Biologics manufacturer? If yes, then this is the assignment for you!
Our biotech client based in Dublin City Centre is currently seeking the expertise of Quality Specialist on a 12 month contract.
Essential Duties and Responsibilities for this Quality Specialist role include, but are not limited to, the following:
- Initiating, writing and managing the complaint investigation to completion.
- 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.
- 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.
- 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.
- 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 - 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
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
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