Cq QA Specialist

3 weeks ago

Johannesburg, South Africa Johnson & Johnson Full time

Description

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:

- Office Administration Skills
- Presentation Skills
- Excellent organization skills.
- Project management.

Attention to detail.
- Communication Skills.

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