Document Control jobs in South Africa

Well known medical equipment supplier requires an experienced QA / RA Administrator. This position is based in Midrand.

AREAS OF RESPONSIBILITY

CHANGE CONTROL MANAGEMENT

Managing the Group Change Management programs and databases in alignment with ISO 13485 requirements and ensuring 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

RECALLS, FIELD SAFETY ACTIONS AND ADVERSE EVENTS

Maintain Index for recalls, field safety actions and adverse events

Prepare draft notification reports for recalls, field safety actions and adverse events

Follow up on the status of recalls, field safety notifications and adverse events till closure report is prepared

Reconcile customer acknowledgments and follow up with respective personnel to ensure recalls are closed timeously

Prepare and provide reports and ensure SAHPRA timelines for reporting is adhered to

Trend KPI data and provide report timeously for Management Review

ASSISTANCE WITH SAHPRA, NRCS, RAD CON, ICASA APPLICATIONS

Support in processes where actions are assigned

Review Change control index per legal entity

Prepare SAHPRA Application packs for QA RA Manager Review and Submission

Maintain index for submissions

Trend KPI data and provide report timeously for Management Review

ASSISTANCE WITH EXPORT REGULATIONS AND ASSOCIATED PRODUCT REGISTERATIONS

Support with investigation of Export requirements

Support with product registrations associated with Export Markets

Sub-distributor evaluation and support on approval process

Trend KPI data and provide report timeously for Management Review

Maintain index for submissions and country requirements

MEDICAL DEVICE FILE

Managing the Group Medical Device File programs and databases in alignment with ISO 13485 requirements and ensure deadlines are not missed for provision of documents

Follow up with allocated department Product Managers and Specialists for Product Dashboards and product lists

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

DOCUMENT CONTROL (External)

Managing the Group Document Control programs and databases in alignment with ISO 13485 and Regulatory requirements and ensure deadlines are not missed

Manage document email address and Shared-Point

Maintain Document Index for internal documents and External documents

eQMS Document Controller Function review and promote documents for approval after review

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

For External documents, ensure review performed and associated review documented, raise associated change controls where applicable

Maintain Document Index for External and external documents

Control the issue of external documents

Retrieval of superseded documents and archiving of digital records

Trend KPI data and provide report timeously for Management Review

POST MARKET SURVEILLANCE

Co-ordination of Post Market Surveillance Program for the Group

Generate and maintain Schedule and follow up with Product Managers until completion of reports

Scan and save reports on respective platforms

Trend KPI data and provide report timeously for Management Review

CUSTOMER COMPLAINT AND ADVERSE EVENT

Managing the Group Customer Complaint and Adverse Event programs and databases in alignment with ISO 13485 and Regulatory requirements and ensure deadlines are not missed

Ensure that complaint timelines are met

Ensure Submissions for Adverse events are met

Do follow-up as needed

Trend KPI data and provide report timeously for Management Review

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 by the timelines

Trend KPI data and provide report timeously for Management Review

TRAINING MANAGEMENT PROGRAM

Managing the Group Training programs and databases in alignment with ISO 13485 requirements and ensure deadlines are not missed

Generate and maintain Training Matrix for Group and all Sites

Generate and Maintain Training Curriculums on eQMS in alignment with Training Matrix and document control program

Follow up on training completion and associated records

• Manage training email address and Training Shared-Point;

Trend KPI data and provide report timeously for Management Review

CALIBRATION MANAGEMENT (Back-up)

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

NON-CONFORMING PRODUCT

Maintain Index for Non-conforming products

Review and retain disposition files

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

Recalls And Adverse Events

Support in processes where actions are assigned

Follow up on open recalls and Adverse Events and ensure on time closure

RAD CON, NRCS, ICASA License Applications

Support in processes where actions are assigned.

Assistance with SAHPRA Applications

Support in processes where actions are assigned

Qualifications

Matric (Grade 12) is a minimum requirement

Diploma, N-Dip or B-tech Degree : Science / Medical / Biological / Technical; (Preferred)

Experience required

5 Years working experience in the Medical, Healthcare, Laboratory Industry (Preferred)

Advanced Computer Skills (MS Office – Word, Excel, PowerPoint, Teams).

Experience with data collection and trending

Experience with Quality Management Systems ISO 13485 or ISO 9001 or any other ISO standard (Preferred)

Experience with Regulatory Affairs and understanding of regulations (Preferred)