Customer Complaints Specialist
|Job Title:||Customer Complaints Specialist|
|Contact Name:||Rachel Radford|
|Job Published:||March 15, 2017 14:18|
- Complaints Management: · Collect and record all customer complaints.
- Liaise with global offices to coordinate complaints.
- Coordinate with Quality Assurance and Tech services groups to ensure minimal delays in responding to customers and to inform product management of issues, progress and responses.
- Formulate initial and final responses directly to customers/distributors.
- Printed Material Coordination.
- Coordinate all Printed Material Changes.
- Review of printed material against FDA, EU, Canadian and ISO guidelines.
- Managing the review and approval of a printed material change, where applicable.
- Chair the effectivity date meeting to review the changeover dates for printed/ packaging material and ensure all documents/data are updated in a timely manner.
- Proof reading of printed material against requested changes.
- Setting up of approved overprinted label template.
- Provide accurate changes to artwork suppliers & approvals to print suppliers.
- Liaise with approved vendors for translation activities.
- Process Document & Data changes related to printed materials changes.
- Assistance with the review of packaging specifications, where necessary.
- Assist with the internal audits and corrective action plans
- Present continuous improvements ideas to processes/procedures.
- May lead Problem Solving, Failure & Root Cause Analysis, Risk Assessment & FMEA activities.
- Comply with Company Policies & Procedures at all times.
- Third level qualification required, science or related discipline would be an advantage.
- Two years' experience working in QA, QC or Regulatory Affairs in the Medical Device or Pharmaceutical industry would be an advantage.
- Working knowledge of the requirements related to complaints & labelling.
- Working knowledge facilitating FMEA Risk Assessments.
- A strong knowledge and understanding of cGMP/GLP requirements.
- Good working knowledge of Microsoft applications.
- Will require demonstrated attention to detail, work with a sense of urgency and have the ability to be impartial and objective.
- Ability to initiate change and improvements as per the regulatory requirements.
If you are interested please don't hesitate to apply!
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