My client a leading and rapidly expanding FDA, cGMP regulated company now require a Senior Quality Complaints Specialist to join their rapidly expanding team.
The Senior Quality Complaints Specialist is responsible for managing the complaints mailbox and input sources and writing product quality complaints and all related activities associated with the complaint handling program per corporate procedure and regulatory standards including goal setting in-line with corporate strategy and priorities and the GQ road map.
Responsibilities of Senior Quality Complaints Specialist:
- Initiating, writing and managing the complaint investigation to completion.
- 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, 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 responses
- 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
- Bachelor's degree with a minimum of 6 years of experience in Quality Assurance or a GMP related field within Medical device, biotechnology or pharmaceutical manufacturing
- 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
- Proven experience with Risk Management and Continuous Improvements.
- Strong Validation experience, particularly with Process Validation regarding NPIs.
- Must have good written & oral communication skills and the ability to communicate with cross functional people.
The RFT Group: Biopharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie / www.meddevicejobs.ie
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