Summary
Overview
Work History
Education
Skills
Work Availability
Timeline
Hi, I’m

Sisonke Notununu

Specification Analyst
Cape Town
Sisonke Notununu

Summary

Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.

Overview

5
years of professional experience
4
years of post-secondary education

Work History

Biovac Institute
Cape Town

Specification Analyst
09.2021 - Current

Job overview


  • Compiles all new specifications on behalf of QC.
  • Review and update current specifications as required (e.g. according to pharmacopoeial updates and changes from the manufacturer).
  • Continuously strive to deliver solutions through teamwork that ensures improvement.
  • Participating in project teams and -supporting other relevant organizational departments with regards to specifications.
  • Participation in quality audits.
  • Participation in technology transfer projects.
  • Ensures compliance in accordance with the Medicines and Related Substances and the organization’s policies, procedures and other applicable laws.
  • Continuously build and support a sound quality assurance culture aligned to cGMP within the organization.
  • Review and update current specifications as required (e.g. according to pharmacopoeial updates and changes from the manufacturer).
  • Liaising with Suppliers on technical Issues where applicable.
  • Ensuring adherence of specifications to Pharmacopoeial updates.
  • Adhere to QC Quality systems and ensure high level of GLP and cGMP.
  • Participate in projects, departmental audits and implement corrective actions where relevant.
  • Compile or amend SOP’s where required.
  • Contribute technical knowledge, experience and learning to quality team with respect to assigned equipment/ processes.
  • Ensure high level of GLP and cGMP in assigned areas, equipment and processes.
  • Maintain up to date working knowledge of assigned equipment/ processes – including knowledge of relevant guidelines.
  • Ensure timely and effective communication.

Biovac Institute
Cape town

QC Inspector
04.2019 - 09.2021

Job overview

· General warehouse/ logistics activities and support.

· Knowledgeable about equipment items and relevant procedures.

· Inspecting, sampling, testing and documenting of incoming material.

· Retention sampling and status labelling.

· Maintaining electronic registers with regards to item release and rejection.

· Adhere to QC Quality systems and ensure high level of GLP and cGMP.

· Participate in projects, departmental audits and implement corrective actions where relevant.

· Compile or amend SOP’s where required.

· Contribute technical knowledge, experience and learning to quality team with respect to assigned equipment/ processes.

· Proactive cost and expense management with risk identification and mitigation in own role.

· Ensure high level of GLP and cGMP in assigned areas, equipment and processes.

· Maintain up to date working knowledge of assigned equipment/ processes – including knowledge of relevant guidelines.


· Ensure timely and effective communication.

SGS Agri Food Laboratory
Cape Town

Laboratory Teschnician
04.2018 - 04.2019

Job overview

-Assist Lab analyst on daily lab work, general housekeeping of equipments for test functions.

- Calibrate and verify instruments, controls and equipment’s for test functions.

- Do analysis in fishmeal and foodstuff for Formaldehyde, ethoxyquin and nitrates and nitrites. Analysis of free fatty acids in oils fishmeal and nuts, Asta colour in spices, sugar colour, sulphur dioxide in food stuff and acidity in juice. Run samples on HPLC and spectrometer

Education

University of The Western Cape
Cape Town

Bachelor of Science from Chemical Science
01.2011 - 06.2015

Skills

Teamwork and Collaboration

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Availability
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Timeline

Specification Analyst

Biovac Institute
09.2021 - Current

QC Inspector

Biovac Institute
04.2019 - 09.2021

Laboratory Teschnician

SGS Agri Food Laboratory
04.2018 - 04.2019

University of The Western Cape

Bachelor of Science from Chemical Science
01.2011 - 06.2015
Sisonke NotununuSpecification Analyst