CQ QA Specialist at Johnson & Johnson

Overall purpose of job:

• The CQ Jnr Specialist is responsible for all activities falling within the ambit of Management of Complaints Handling And Adverse Event Reporting Processes; To drive execution and delivery of QS & C components to ensure compliance with relevant metrics. Management of Metrics. Management Review.Enhance quality of data input, investigation, stakeholder involvement and final submission. Management of Recalls/Stop Shipments/Field Safety and Corrective Actions as back-up; Inspection and Releases of Packaging Material and Final Repacked/Relabeled Products, as back-up. Management of Document Control for the Artwork/Specification Process, as back-up. To participate in global and local projects which may or may not include South Africa as part of the scope.

Essential duties and responsibilities:

Complaint Handling and Handling of Adverse Event Reporting

• Daily monitoring of complaints
• Weekly preparation of report, with feedback to CQ Manager
• No aging open activities
• Timely Feedback to Reps on Analysis Feedback from Franchise once Investigation is completed.
• Prepare formal letter upon request within 3 working days.
• On time reporting of Adverse Events to SAPHRA within stipulated time frames
• Packaging and despatch of product quality complaint products returned
• Monitoring of Service and Repair Complaints and escalating when required
• Updating of the Adverse Event Tracker
• Hold monthly DSI meetings with Customer Service to monitor DSI with potential for or with patient impact
• Participate actively in EMEA bi-w eekly meetings

Training

• Induction Training
• Process Training of JnJ Personal and Distributors
• Completion of training assigned by the required due date
• Update user groups and assign training CAPA Management
• Weekly internal CAPA meetings to track progress and advise on quality of data captured
• Logging of QI/CAPA/Non-Conformances and management of output
• Performance of Effectiveness Checks and preparation of memosChange Control
• Attend weekly change control meetings to track and address any actions that are problematic
• Initiate change controls where required

Audits

• Prepare and participate in ISO 9001:2015 – Recertification Audit Preparation and Audit
• Prepare for and participate in internal audits

Management Review

• QSMR Preparation and Presentation
• Process documentation (deck, checklist, attendance forms, minutes and certification form) within required timeframes and correctly
• Conduct Management Review as per relevant SOP (minimum twice a year)
• Uploading into storage platform
• Raise action items as commitment records in TrackWise
• Implement Governance meetings and track activities to closure

Metrics

• Uploading of metrics into required platform by due date
• Providing comment where required, by due date

Document Management

• Preparation and uploading of documents into TruVault as per procedure

Qualifications

Job Requirements

Essential knowledge and skills:

• Education and experience (minimum necessary to perform job):
• Matric
• Quality Control in a GMP Facility – 1 Year
• QMS Knowledge

Core competencies required for this role:

• Computer Literacy (including but not limited to Excel, Power Point, Email)
• Office Administration Skills
• Presentation Skills
• Excellent organization skills.
• Project management.

Attention to detail.

• Communication Skills.