National QA Ra Specialist

2 weeks ago

Johannesburg, South Africa Ultra Personnel Full time

2-5 Years working experience in the medical industry under a Quality Management System
Matric / Gr 12 is the minimum requirement for this position
Qualification in relation to Quality Management Systems is preferred

**Diploma, N-Dip or B-tech Degree**: Science/ Medical / Biological/ Technical/ Quality is preferred
Lead Auditor ISO 13485:2016 or ISO 9001:2015 Certification will secure
Project Management qualification will be advantageous
Quality Management System
Advanced Computer Skills (MS Office Word, Excel, Powerpoint, Teams]

**Date Issued**: 24 February 2023 Internal Use Only Page 3 of 3
Experience with data collection and trending
Experience with Quality Management Systems ISO 13485 or ISO 9001 or any other ISO standard (required)
Experience with CAPA, Non-conformance, Self-inspections or Internal Audits, Supplier Quality
Experience or working knowledge in Regulatory Affairs and understanding of regulations associated with SAHPRA, Radiation Control, NRCS, ICASA (preferred)
Required working knowledge of ISO 13485:2016 Quality Management Systems, with experience preferred
Working knowledge of Validation practices;
Working understanding of CE Products, FDA approved products
Must have a valid drivers licence and own vehicle
Must be willing to travel locally and internationally
Must have a valid passport

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 and determining CAPA plans
Trend KPI data and provide report timeously for Management Review

Nonconformance / Deviation Management

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

Internal and 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 nonconformities 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

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

Risk Management

Managing and maintaining the Risk Files for areas under responsibility in alignment with ISO 13485 requirements and ensure deadlines are not missed for associated activities
Trend KPI data and provide report timeously for Management Review

Validation

Managing and Maintaining Validation Schedules
Support in validation activities for areas under responsibility
Support departments in validation document compilation and review as assigned
Support in execution of validation execution as assigned

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

General

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

Recall and Adverse events
RAD Con, NRC, ICASA Licence Applications
Assistance with Sahpra Applications

  • Ra/qa Pharmacist

    2 days ago

    Johannesburg, South Africa Measured Ability Group Holdings Full time

    **South Africa - Gauteng**, Johannesburg - North (Sandton / Midrand / Diepsloot)** **R750 000 - R800 000 Our Pharmaceutical client is looking for a RA/QA Pharmacist to join their Animal Health division. **Key requirements** - B. Pharm degree with at least 2 years of experience in compilation of new dossier and variations to SAHPRA - Experience in dealing...

  • National QA Manager

    Found in: Talent ZA 2A C2 - 3 weeks ago

    Johannesburg, South Africa Isilumko Staffing (JHB) Full time

    A well known diagnostic pathology service client is looking for an experienced individual to join their team as a National QA Manager. Responsibilities:Management of QA schemes and national accreditationDrive cost effectivenessRegular management of the execution of lab technical auditsAssist with SANAS accreditationAssist with quality auditsManagement of...

  • National QA Manager

    Found in: Talent ZA C2 - 3 weeks ago

    Johannesburg, South Africa Isilumko Staffing Full time

    A well known diagnostic pathology service client is looking for an experienced individual to join their team as a National QA Manager. Responsibilities:Management of QA schemes and national accreditationDrive cost effectivenessRegular management of the execution of lab technical auditsAssist with SANAS accreditationAssist with quality auditsManagement of...

  • National QA Manager

    Found in: Whatjobs ZA C2 - 6 days ago

    Johannesburg, South Africa Isilumko Staffing (JHB) Full time

    A well known diagnostic pathology service client is looking for an experienced individual to join their team as a National QA Manager.  Responsibilities: Management of QA schemes and national accreditation Drive cost effectiveness Regular management of the execution of lab technical audits Assist with SANAS accreditation Assist with quality audits...

  • Ra/pv Specialist

    4 days ago

    Johannesburg, South Africa Organon Full time

    Organon is a Women’s Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our...

  • Specialist QA Engineer

    Found in: Talent ZA 2A C2 - 3 weeks ago

    Johannesburg, South Africa TalentCru Full time

    Are you a seasoned QA Engineer with a passion for Salesforce and a knack for cutting-edge voice technology solutions? Look no further! We're hiring a Specialist QA Engineer to join our Everyday Banking Cluster on a 12-month contract. 3-5 years in Salesforce.3-5 years Contact Centre experience.5 years IT industry/Financial services. Industry...

  • Regulatory Affairs Specialist

    7 days ago

    Johannesburg, South Africa Abbott Laboratories Full time

    **Job Title** **Regulatory Affairs Specialist (1-Year Fixed-Term Contract)** **About Abbott** Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. **Working at Abbott** - At Abbott, you can do work that matters,...

  • QA Lead

    7 days ago

    Johannesburg, South Africa Nedbank Full time

    **Requisition Details & Talent Acquisition Consultant** - REQ 118765 - Keabetswe Modise**Job Family** - Informaton Technology**Career Stream** - IT Operations**Job Purpose** - To Lead the Test Implementation in accordance with the agreed Quality Assurance principles and standards in order to manage the Product risk and inter-dependencies during the Product...

  • QA Lead

    4 days ago

    Johannesburg, South Africa Nedbank Full time

    **Requisition Details & Talent Acquisition Consultant** - REQ 119635 - Keabetwe Modise- Job Family- Informaton Technology- Career Stream- IT Operations- Leadership Pipeline- Manager of Others**Job Purpose** - To Lead the Test Implementation in accordance with the agreed Quality Assurance principles and standards in order to manage the Product risk and...

  • Proof Reader

    7 hours ago

    Johannesburg, South Africa Ultra Personnel Full time

    Matric essential Medical Diploma / Degree is an advantage The ability to read and understand clinical trials is a must ie. Regulatory or QA experience in the pharmaceutical / medical industry Proof reading all agency materials from first layout to print proof to ensure style, consistency, clarity and readability, trademarks, registration information,...

  • National Marketing Specialist

    2 days ago

    Johannesburg, South Africa Six Sense Full time

    Gauteng, JHB - Eastern Suburbs Well established stationary business seeking National Marketing Specialist. A vacancy exists for an experienced, energetic and motivated National Marketing Specialist. **DUTIES WILL INCLUDE**: - Promotion Planning and Innovation - Obtain and review Briefing Documents. - Brief promotions to graphic designer or agency as needs...

  • National Manager: Quality Assurance

    Found in: Talent ZA C2 - 3 weeks ago

    Johannesburg, South Africa Tipp Focus Full time

    Main Purpose of the JobManage the national quality assurance within the company to ensure the provision of a high-quality laboratory service for the clients in line with business needs.Key Job ResponsibilitiesManage the National Accreditation, QA schemes of company to assist laboratories to attain optimal performance.Advise on company subscriptions to other...

  • Data Intergration Specialist

    2 weeks ago

    Johannesburg, South Africa National Renal Care Full time

    National Renal Care has grown and evolved into the leading total kidney disease management organisation that provides person-centred health and care, which is digitally enabled, and data driven. National Renal Care seeks to recruit an ambitious, talented, goal driven and self-motivated individual to fulfil the role of a Data Integration Specialist. ROLE...

  • Audit Inspector Financial Service Specialist

    2 days ago

    Johannesburg, South Africa Affirmative Portfolios Full time

    **FINANCIAL SERVICE SPECIALIST**: **Finance** **JHB East** ***: **AUDIT INSPECTOR** **FINANCIAL SERVICE SPECIALIST** **REMUNERATION: Highly competitive salary and other attractive benefits** **JOHANNESBURG NORTH** **Department - **Inspections **Overview**: Auditing specialist and a passion for Auditing - Protect the public and integrity of the auditing...

  • National Manager: Quality Assurance

    Found in: Talent ZA 2A C2 - 3 weeks ago

    Johannesburg, South Africa Isilumko Staffing (JHB) Full time

    Key Job Responsibilities:1. Oversee the National Accreditation and Quality Assurance (QA) programmes to support laboratories in achieving optimal performance standards.2. Provide guidance on selecting subscriptions to national and international External Quality Assessment (EQA) schemes, ensuring cost-effectiveness and exploring alternative options when...

  • National Manager: Quality Assurance

    Found in: Talent ZA C2 - 3 weeks ago

    Johannesburg, South Africa Isilumko Staffing Full time

    Key Job Responsibilities:1. Oversee the National Accreditation and Quality Assurance (QA) programmes to support laboratories in achieving optimal performance standards.2. Provide guidance on selecting subscriptions to national and international External Quality Assessment (EQA) schemes, ensuring cost-effectiveness and exploring alternative options when...

  • National Manager: Quality Assurance

    Found in: Whatjobs ZA C2 - 6 days ago

    Johannesburg, South Africa Isilumko Staffing (JHB) Full time

    Key Job Responsibilities: 1. Oversee the National Accreditation and Quality Assurance (QA) programmes to support laboratories in achieving optimal performance standards. 2. Provide guidance on selecting subscriptions to national and international External Quality Assessment (EQA) schemes, ensuring cost-effectiveness and exploring alternative options when...

  • Specialist : Social Impact Design

    Found in: beBee S ZA - 4 weeks ago

    Gauteng, Johannesburg, South Africa National Youth Development Agency Full time

    National Youth Development Agency’s job vacancy, Career and Recruitment Job title : Specialist : Social Impact Design jobs in Gauteng Job Location : Gauteng, Johannesburg Deadline : May 03, 2024 Quick Recommended Links Jobs by Location Job by industries Qualification: NQF Level 7 (Bachelor’s degree or equivalent qualification in Sustainable...

  • Specialist : Social Impact Design

    Found in: beBee S ZA - 3 weeks ago

    Gauteng, Johannesburg, South Africa National Youth Development Agency Full time

    National Youth Development Agency’s job vacancy, Career and Recruitment Job title : Specialist : Social Impact Design jobs in Gauteng Job Location : Gauteng, Johannesburg Deadline : May 03, 2024 Quick Recommended Links Jobs by Location Job by industries Qualification: NQF Level 7 (Bachelor’s degree or equivalent qualification in Sustainable...

  • National Quality Assurance Manager

    Found in: Talent ZA 2A C2 - 3 weeks ago

    Johannesburg, South Africa Isilumko Staffing (JHB) Full time

    Are you passionate about ensuring the highest standards of quality in laboratory services? Do you possess the leadership skills and expertise to manage national accreditation and quality assurance schemes? If so, we have an exciting opportunity for you!Key Job Responsibilities:Manage the National Accreditation and Quality Assurance schemes of THE COMPANY to...