2X QA Administrator

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 2XQA Administrator to join a goal-oriented team.

QUALIFICATIONS NEEDED:

• Grade 12/ Matric or equivalent.

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

• At least 3 years experience within a similar position and environment equivalent.
• Technical and Computer Literacy.

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 for archiving timeously to the company service providers in the event of a shortage of space on-site occurs.
• Ensure that the off-site archiving procedures is 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.

Trackwise Administration:

• Ensure that all updated SOPs WIs are released on time on the Training Management System on Trackwise.
• Ensure that all new assessment questionnaires and updates are performed on time and are accurate.
• Ensure administrative support is provided when required with the QA Department.
• Ensure that all documents/procedures within the training department are reviewed and updated within the prescribed timelines.
• Capture of Risk assessment actions and communication to site on outstanding actions.

General Administration:

• QA administrative support including photocopying scanning filing 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.

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 for update to Standard forms and ensure appropriate logbooks are printed and issued.

Application Deadline: 25 February 2025

If you do not receive a response from us within three weeks of submitting your application please understand that your application was not successful.

We believe in the magic of diversity within teams and to achieve this we do apply Employment Equity principles during our selection process where this is necessary to achieve such diversity.

Disclaimer:

Dear Applicant we appreciate your interest in joining our organization. It is imperative for us that you understand how we handle your information. We are committed to ensuring the security and confidentiality of the information you provide. Your personal details will be collected for the sole purpose of the application process and will be used strictly for that purpose. By applying you acknowledge and consent to the collection use and protection of your personal information in accordance with our privacy policy. If you have any inquiries or concerns our Human Capital department is available to provide clarification. We look forward to reviewing your application.