Quality Assurance Representative

Quality Assurance Representative

Position Details

Position Title: Quality Assurance Representative
Location: Roodeplaat
Classification: Permanent
Employment Equity: Preference will be given to EE applicants

Closing Date: 21 January 2021

Please take note:
Only shortlisted candidates will be contacted. Deltamune may expire jobs at their own discretion.

Deltamune (Pty) Limited, an independent centre of excellence, is a South African-based biotechnology company. Our focus is on veterinary health offering vaccines on a commercial scale. Deltamune’s veterinary vaccine range includes registered and autogenous vaccines for poultry, ruminants and other species. Deltamune invites all suitably qualified and experienced candidates to apply for the following vacancy:

Position Purpose

Responsible for the establishment, implementation and maintenance of appropriate Quality Systems for Product Development. To assist with the implementation of Deltamune policies and procedures to ensure that all Quality System requirements are met for all product development projects. To ensure that all the facility requirements, procedures and processes needed to comply with the applicable biosafety requirements are established, implemented and maintained.

Key Accountabilities:
  • Implementation of Deltamune policies and procedures to ensure that all appropriate quality requirements are met for product development projects within Product Development
  • Ongoing training of all personnel into the quality and biosafety principles as required by regulatory authorities
  • Schedule and co-ordinate the calibration/verification equipment critical to accurate performance of product development studies.
  • Conduct internal audits to determine if product development studies are conducted in compliance with Deltamune Quality System principles
  • Performing system or facility-based inspections
  • Responsible for documenting and reporting of all inspections performed
  • Co-ordination for audits of study data and final reports to ensure, with the assistance of a specialist as required, the following:
    • Auditing of final reports to determine if the study was carried out in accordance with the study plan and SOP’s.
    • Determine whether a study has been accurately and completely reported
    • Determine if the report contains all the elements required by the Quality System
    • Determine if the report is internally consistent and that raw data are complete and in compliance with the Quality System
    • Ensure that all issues raised in the QA audit have been appropriately addressed in the final report and that all agreed actions have been completed.
    • Ensure that any corrections or additions to a completed final report is audited and a revised additional QA statement provided.
  • Investigate, recommend and implement an appropriate Documentation System to support the Quality System
  • Responsible for the document control of the Product Development Department
  • Maintain copies of all approved study plans and related Standard Operating Procedures (SOP’s)
  • Responsible for the review of SOP’s before use to assess their clarity and compliance with Quality System Principles
  • QA inspections of suppliers and contractors
  • Provide feedback on QA performance and any needs for improvement

Deltamune (Pty) Limited, an independent centre of excellence, is a South African-based biotechnology company. Our focus is on veterinary health offering vaccines on a commercial scale. Deltamune’s veterinary vaccine range includes registered and autogenous vaccines for poultry, ruminants and other species. Deltamune invites all suitably qualified and experienced candidates to apply for the following vacancy:

Position Purpose

Responsible for the establishment, implementation and maintenance of appropriate Quality Systems for Product Development. To assist with the implementation of Deltamune policies and procedures to ensure that all Quality System requirements are met for all product development projects. To ensure that all the facility requirements, procedures and processes needed to comply with the applicable biosafety requirements are established, implemented and maintained.

Key Accountabilities:
  • Implementation of Deltamune policies and procedures to ensure that all appropriate quality requirements are met for product development projects within Product Development
  • Ongoing training of all personnel into the quality and biosafety principles as required by regulatory authorities
  • Schedule and co-ordinate the calibration/verification equipment critical to accurate performance of product development studies.
  • Conduct internal audits to determine if product development studies are conducted in compliance with Deltamune Quality System principles
  • Performing system or facility-based inspections
  • Responsible for documenting and reporting of all inspections performed
  • Co-ordination for audits of study data and final reports to ensure, with the assistance of a specialist as required, the following:
    • Auditing of final reports to determine if the study was carried out in accordance with the study plan and SOP’s.
    • Determine whether a study has been accurately and completely reported
    • Determine if the report contains all the elements required by the Quality System
    • Determine if the report is internally consistent and that raw data are complete and in compliance with the Quality System
    • Ensure that all issues raised in the QA audit have been appropriately addressed in the final report and that all agreed actions have been completed.
    • Ensure that any corrections or additions to a completed final report is audited and a revised additional QA statement provided.
  • Investigate, recommend and implement an appropriate Documentation System to support the Quality System
  • Responsible for the document control of the Product Development Department
  • Maintain copies of all approved study plans and related Standard Operating Procedures (SOP’s)
  • Responsible for the review of SOP’s before use to assess their clarity and compliance with Quality System Principles
  • QA inspections of suppliers and contractors
  • Provide feedback on QA performance and any needs for improvement

Position Details

Position Title: Quality Assurance Representative
Location: Roodeplaat
Classification: Permanent
Employment Equity: Preference will be given to EE applicants

Closing Date: 21 January 2021

Please take note:
Only shortlisted candidates will be contacted. Deltamune may expire jobs at their own discretion.

Specifications

Qualifications:
  • Quality Control qualification
Knowledge / Experience:
  • At least 3 years working experience in a research and development environment in the microbiological/veterinary/pharmaceutical industry is an essential.
  • Experience working in Biosafety level 3 facilities will be an advantage.
  • Previous experience in the implementation and maintenance of GLP/GCP in a research and development environment is a strong recommendation
  • Knowledge and experience in sterile microbiological techniques and biological product production processes essential
  • Knowledge of biosafety practices and procedures is essential
Skills / Attributes / Competencies:
  • Ethical and high integrity.
  • Excellent verbal communication skills.
  • Excellent interpersonal skills, including flexibility and the ability to work well in a team environment.
  • Time management skills.
  • Microsoft Excel and Word Intermediate Level.
  • Applicant must be energetic and healthy.
Additional requirements:

Must be:

  • Willing and able to be trained to work in a biosafety level 3 environment
  • Willing to undergo a medical examination for biosafety level 3 clearance
  • Must have own transport with valid code 08 license.
Qualifications:
  • Quality Control qualification
Knowledge / Experience:
  • At least 3 years working experience in a research and development environment in the microbiological/veterinary/pharmaceutical industry is an essential.
  • Experience working in Biosafety level 3 facilities will be an advantage.
  • Previous experience in the implementation and maintenance of GLP/GCP in a research and development environment is a strong recommendation
  • Knowledge and experience in sterile microbiological techniques and biological product production processes essential
  • Knowledge of biosafety practices and procedures is essential
Skills / Attributes / Competencies:
  • Ethical and high integrity.
  • Excellent verbal communication skills.
  • Excellent interpersonal skills, including flexibility and the ability to work well in a team environment.
  • Time management skills.
  • Microsoft Excel and Word Intermediate Level.
  • Applicant must be energetic and healthy.
Additional requirements:

Must be:

  • Willing and able to be trained to work in a biosafety level 3 environment
  • Willing to undergo a medical examination for biosafety level 3 clearance
  • Must have own transport with valid code 08 license.
Apply Now

    First Name*
    Last Name*

    Quality Assurance Representative

    Email*
    Phone*

    Identity/Passport Number*

    Driver's License YesNo
    Own Transport YesNo
    Last Salary Earned (Before Deductions)*
    Salary Expectation (Before Deductions)*
    Name of City/Town Currently Residing In*
    Notice Period Required*

    What qualification do you have in quality control?

    How many years experience do you have in Quality Control?

    Are you familiar with a BSL3 Laboratory?

    Do you come from a research and development background?

    Reason for being in the job market.*

    How did you hear about this vacancy*

    Attach CV:*

    Attach Copy of Drivers License

    Attach Copy of last payslip:

    Attach Copy of ID:*

    Attach Copy of Qualification:*