2X QA Systems and Training Administrator FTC at Biovac

• BIOVAC is one of the leading sterile vaccine manufacturers rooted in Africa, with our core purpose being to "protect life". We are looking to hire a dynamic, passionate, confident, proactive and meticulous 2X QA Systems and Training Administrator FTC to join a goal-oriented team.

QUALIFICATIONS NEEDED:

• Diploma in Business Administration or equivalent.
• Grade 12/ Matric or equivalent.
• Recognition is given to Prior Learning and practical experience.

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

• At least 3 years' experience within a similar position and environment.
• Technical and Computer skills such as MS Office (Word, PowerPoint, Excel), MS Teams and Outlook
• Document management e.g., filing, archiving, retrieval of documents

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

Core Technical Delivery

Management of Archives:

• Ensure that documents and records are submitted to Archive center are in good order, up to date, and GdocP compliant.
• Ensure that documents submitted for archiving is logged into archive logbook.
• Ensure that documents and records are archived within a BIN, and logged onto Archive Index, with the document contents and unique archive position.
• All Archive documents to be scanned in electronic folders as per specific categories.
• Ensure that a tracking mechanism is in place for easy traceability, using the unique BIN location numbering system.
• Identify gaps and duplication.
• Ensure that the retention periods for hard copies are adhered to as per stipulated in the Archive SOP.
• Update and maintain document information management systems register(s) as per the SOP and ensure correct and timeous turnaround times.
• Review SOP, WI and other related documentation applicable to the Archive center on request and when required.
• Making records available to users in online formats.
• Evaluating, selecting, retrieving and arranging materials.
• Answering documentation enquiries.
• Storing and preserving perishable documents.
• Document administration with Pharmaceutical Quality System documents.
• Record administration and archiving.
• Filing of documents and the management of the Archive database.
• Coordinate the document/ software sign-out, and retrieval within the Archive where applicable, e.g. Batch Books.
• General administration including filing (electronic and hard copies), scanning, assisting in audits, minute taking.
• Ensure effective and timely communication and escalation to the appropriate levels of management.
• Ensure that GMP Documents and Records are sent off-site to archive timeously to the company's service providers, in the event of a shortage of space on-site occurring.
• Ensure that the off-site archiving procedures are compliant with the providers procedures with archiving at their facility and retrieval for Biovac.
• Ensure that retention times are adhered to as per the SOP.
• Ensure that Archive center is audit ready for both internal and external bodies.

General Administration:

• QA administrative support includes photocopying, scanning, filing, and delivering documents to various stakeholders and any other administrative needs required in the QA department.
• Provide and capture department KPI and metrics as periodically required.
• Issue Risk assessment numbers to site.
• Capture of Risk assessment actions and communication to site on outstanding actions.

Logbook Administration:

• Creation of logbooks on time.
• Review of logbooks for adherence to good documentation practices.
• Issue of logbooks to user departments on time.
• Retrieval and archiving previous version of logbooks.
• Monitor Trackwise to update to Standard forms and ensure appropriate.