Junior QA & RA Administrator | Medical Devices | Gauteng

AREAS OF RESPONSIBILITY

DOCUMENT CONTROL

• Managing the Group Document Control programs and databases in alignment with ISO 13485 requirements and ensure deadlines are not missed;
  
• Manage document email address and Shared-Point;
  
• Maintain Document Index for internal documents;
  
• eQMS Document Controller Function review and promote documents for approval after review;
  
• Support teams with generation formatting and content creation of SOP s;
  
• Issue approved documents for training and follow up to completion as per training matrix create implementation pack for document to be rendered effective;
  
• Effective documents to be distributed within the organisation as digital and hard copies;
  
• Retrieval of superseded documents and archiving of digital records;
  
• Trend KPI data and provide report timeously for Management Review
  

EXTERNAL DOCUMENT CONTROL

• Maintain Document Index for External and external documents;
  
• Control the issue of external documents;
  
• Review internal and external documents and perform GAP assessment raise change controls and update documents to align with external document requirements;
  
• Retrieval of superseded documents and archiving of digital records;
  
• Trend KPI data and provide report timeously for Management Review.
  

NONCONFORMANCE/ DEVIATION MANAGEMENT

• Managing the Group and individual site Nonconformance/ Deviation databases in alignment with ISO 13485 requirements and ensure deadlines are not missed;
  
• Support departments with investigations and determining root causes of non conformities and ensure CAPAs process initiated where required;
  
• Trend KPI data and provide report timeously for Management Review.
  

NON-CONFORMING PRODUCT

• Maintain Index for Non-conforming products;
  
• Review and retain disposition files;
  
• Trend KPI data and provide report timeously for Management Review.
  

CAPA

• Managing the Group and individual site Corrective and Preventative Action programs and databases in alignment with ISO 13485 requirements and ensure deadlines are not missed;
  
• Support departments with investigations and determining root causes of non conformities;
  
• Trend KPI data and provide report timeously for Management Review.
  

INTERNAL & EXTERNAL AUDITS

• Perform allocated internal audits as assigned;
  
• Managing the Group and individual site Internal Audit databases in alignment with ISO 13485 requirements and ensure deadlines are not missed;
  
• Support departments with investigations and determining root causes of non conformities and ensure CAPAs process initiated where required;
  
• Trend KPI data and provide report timeously for Management Review;
  
• Support with External Audits as per allocated actions.
  

SUPPLIER QUALITY

• Managing the Group and individual site Supplier Quality programs and databases in alignment with ISO 13485 requirements and ensure deadlines are not missed for monitoring and evaluations;
  
• Perform assigned Supplier Audits;
  
• Review and evaluation of the Approved Supplier List and suppliers as well as raising and communicating supplier non-conformances (Supplier Quality Liaison);
  
• Initiate Change Controls for supplier change notifications received and follow up on actions ensuring completion per timelines;
  
• Trend KPI data and provide report timeously for Management Review.
  

CHANGE CONTROL MANAGEMENT

• Managing the Group Change Management programs and databases in alignment with ISO 13485 requirements and ensure deadlines are not missed;
  
• Schedule change meetings and ensure change initiation documents are available;
  
• Maintain Change Control Index and follow up on action completion;
  
• Collate change control action evidence and once all evidence available prepare change pack for implementation and approval;
  
• Trend KPI data and provide report timeously for Management Review
  

CUSTOMER COMPLAINT MANAGEMENT

• Managing the Group Customer Complaint Management programs and databases in alignment with ISO 13485 requirements and ensure deadlines are not missed;
  
• Customer complaint receipt coordination and maintaining databases and ensure that deadlines are met by the Group in resolving and providing information to the suppliers for product complaints;
  
• Assist and support departments with internal complaint investigations root cause identification and CAPA determination;
  
• Notify Product Manager Sales Manager and Sales Rep promptly on receipt of investigation results for reporting to customer;
  
• Trend KPI data and provide report timeously for Management Review.
  

RISK MANAGEMENT

• Set Up Process and Risk Files and continuous maintenance and improvement of the system;
  
• Analysis of risk and implementation of corrective actions for Quality Management Systems. Support Teams with Product Risk
  
• Assessments in accordance with Group policies and procedures ISO 13485 and statutory and regulatory requirements;
  
• Managing the Group Risk Management programs and databases in alignment with ISO 13485 requirements and ensure deadlines are not missed;
  
• Trend KPI data and provide report timeously for Management Review
  

VALIDATION

• Managing and Maintaining Validation Schedules;
  
• Generate validation protocols and reports and support departments where applicable;
  
• Support in validation activities for areas under responsibility;
  
• Follow up with teams until completion of activities;
  
• Trend KPI data and provide report timeously for Management Review.
  
  

KPI DATA COLLECTION AND ANALYTICS

• Follow up with all sites and departments on monthly KPI data metrics;
  
• Ensure data is provided as per approved KPI Metrics;
  
• Perform data analysis and trending remarks
  

• Managing the Group Calibration programs and databases in alignment with ISO 13485 requirements and ensure deadlines are not missed for Calibration;
  
• Maintain and update Calibration Index and update Shared-Point with calibration certificates for the group;
  
• Trend KPI data and provide report timeously for Management Review.
  
• Trend KPI data and provide report timeously for Management Review.
  

GENERAL

• Support with External Audits as per allocated actions:
  
• Document Control
  
• Reviewing and updating of Standard Operating Procedures and Quality Documents;
  
• General administrative duties including archiving filing issue of Quality Documents
  
• Training
  
• Ensure assigned training is completed timeously.;
  
• Provide training on areas under responsibility.
  
• Continuous Improvement
  
• Individual Quality Improvement Projects are assigned on an annual basis are completed in a timeous manner;
  
• Identify improvement areas in processes under responsibility.
  

RAD CON NRCS ICASA LICENCE APPLICATIONS

• Support in processes where actions are assigned.
  

ASSISTANCE WITH SAHPRA APPLICATIONS

• Support in processes where actions are assigned
  

Requirements

Qualifications

• Matric / Gr12 minimum requirement;
  
• Degree: Science/ Medical / Biological/ Technical (Preferred)
  

• Advanced Computer Skills (MS Office Word Excel PowerPoint Teams) -Non-Negotiable;
  
• 2-5 Years working experience in the Medical Industry Non-Negotiable
  
• Experience with data collection and trending;
  
• Experience with Quality Management Systems ISO 13485 or ISO 9001 or any other ISO standard Non Negotiable;
  
• Experience with Regulatory Affairs and understanding of regulations Preferred.
  

Capabilities

• Highly organized with attention to detail producing and expecting highly accurate work within allocated timelines;
  
• Methodical and logical structure of executing activities;
  
• Excellent interpersonal skills;
  
• Ability to develop lead and maintain an effective action completion;
  
• Fluent in English verbal and written;
  
• Ability to operate & communicate at all levels verbally & in writing;
  
• Able to follow and issue verbal and written instructions;
  
• Flexible conscientious approach;
  
• Logical approach to good problem solving and solution driven;
  
• Energetic and able to work independently;
  
• Follow up skills and ability to be assertive in meeting deadlines.
  
• Willingness to learn and someone who has a hunger to grow and make a difference