Junior Change Control & Compliance Scientist (12 month contract) - AA - CPT or JHB

SUMMARY:
Our client is looking for a Junior Change Control & Compliance Scientist for a 12-month contract. Candidate e can be based in JHB or CPT. AA candidates only

POSITION INFO:

Job Specification

Responsible for ensuring that all Change Controls received for assessment from QA are logged in the Change Control tracker

Reviewed within the specified turnaround time

Correct amendment categorization is applied 

Technical review of proposed Change Controls for Quality Impact before providing a Go-No-Go decision 

Review and approve / or reject change  control requests as per SOP/SLA

Ensure the correct amendment classification is assigned with timeous communication to the unit/LCM team

Review and approval of 3rd Party master documentation 

Ensures compliance to regulatory requirements for Master documents by procuring and maintaining a database for Batch Manufacturing Records, Batch Packing Records, Finished Product Specifications, API specifications, Analytical Methods, and Validation Protocols

Performs the QA due diligence process for new product launches

Supporting the release of the product to market within project timelines and for acquisitions to support new business in decision making

Training of new employees within the change control team as guided by the change control scientist

Provide monthly statistical analysis of Change Controls and Master documentation to support the monthly QA report and QMR

Minimum Requirments

1-year work experience in a Regulatory Affairs department of a pharmaceutical company

In addition, at least 1 year of work experience in a quality assurance or quality control department of a pharmaceutical company 

Acute Attention to detail

Analytical skills

12-month contract

AA candidates only

JHB or CPT based

Kindly note that by submitting your application for this career opportunity you agree that Guardian Recruiting may use your application for the purpose of the recruitment and selection of the said position and this information may be shared with the relevant stakeholders in the business.

Please note that only shortlisted candidates will be contacted.

Should you not have heard back within a two-week period, please assume that your application was unsuccessful. All job postings are in accordance with our Client''s BEE requirements. Please only send certificates when requested to do so.

NB! This job is now closed. You can apply for other jobs by uploading your CV.