Complaints Processing Analyst – Mayo

Desired Skills: complaints,administration,documentation

PE Global is currently recruiting for QA Analyst for a Client site in Westport:

This will be a 12-month initial contract role – onsite for training with hybrid potential thereafter (3 days onsite)

Title:  Complaint Processing Analyst

Purpose:

The Complaints Processing Analyst will report directly to the complaints manager and coordinate the handling of customer complaints investigations, trending, and analysis for all commercial & clinical products, working with internal departments on Root Cause Problem Solving cases to ensure implementation of robust Corrective/Preventive action plans and tracking these to completion. The Complaints Processing Analyst is responsible for opening, tracking and maintain records for complaints received and data entry into complaint handling system. The Complaints Processing Analyst is responsible for coordinating cross-functional activities in the investigation of Adverse Event/ Product Quality and customer service complaints and determination of root cause including the coordination of laboratory testing of complaint samples.

Responsibilities:

• Assure complaint records meet global requirements.
• Product complaint documentation, investigation, and review of all non-medical complaint content.
• Responsible for reviewing medical complaints that involve a non-medical quality related problem.
• Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GCP. This required good analytical skills, technical writing, and good documentation.
• Identification of potentially reportable events and notification to appropriate functional groups and management.
• Serve as main resource for the team or a subject matter expert on complaint handling.
• Liaise with site complaint investigation team to achieve closure of complaint cases in a timely manner.
• Attend all meetings as requested by the Complaints Manager or arrange an appropriate deputy.

Requirements:

• Bachelor Degree in Sciences or related field.
• 1-2 years previous experience in pharmaceutical industry or industry placement.
• Previous experience in the use of SAP and Trackwise and Document management systems is desirable.
• Knowledge of global regulatory requirements for pharmaceutical, medical device and combination products.
• Proficient computer skills including Word, Excel.
• Strong CAPA knowledge, decision making and critical thinking abilities.
• Excellent written, communication and interpersonal skills.
• Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures.
• Ability to work with cross-functional teams and to interact effectively with peers, management and customers.
• Good time management and organizational skills.

Interested candidates should submit an updated CV, marked for the attention of Audrey

audrey.mccarthy@peglobal.net  or  00353 21 4297900