Quality Assurance Coordinatoroutsource Ftc

2 weeks ago

Cape Town, South Africa Biovac Full time

**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 Quality Assurance Coordinator - Outsource FTC to join a goal-oriented team.

**QUALIFICATIONS NEEDED**:

- Grade 12 / Matric / Equivalent
- Recognition is given to Prior Learning and practical experience.

**NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE**:

- At least 2 3 years in a similar environment.
- Pharma/ Biotechnology/ FMCG industry experience is highly advantageous.
- Knowledge of supplier/vendor auditing advantageous
- Experience in having faced successfully local and/ or international quality audits.
- Experience in aseptic (Sterile) manufacturing.

**KEY DUTIES & RESPONSIBILITIES OF THE ROLE**:
**Vendor certification**
- Keep vendor certification system up to date.
- Follow up with departments on vendor certification approval and assessments.
- Coordinate and facilitate the vendor certification documentation for approval.
- Manage conditionally approved and approved vendors.
- Update and maintain AVL.
- Prepare Vendor Monitoring reports as per the schedule.

**Vendor file management**
- Keep the database (Trackwise and SharePoint) of vendors and hardcopy files of vendors up to date.
- Ensure all certificates are current and request new ones from vendors when expired
- Send postal audits out to vendors and follow up on outstanding postal audits.
- Follow up on outstanding site audit reports and observation close-out.

**External audits and Vendor Audits**
- Assist in the coordination and organization of third-party and regulatory audits.
- Assist with departmental documentation preparation for third-party and regulatory audits.
- Assist with company response documentation preparation for third-party and regulatory authorities.
- Ensure all documentation is filed and up to date.
- Create and maintain Postal Audit Schedule.

**Quality and Technical Agreements and Change Notification Agreements**
- Maintain Agreement Tracker and monitor expiry dates.
- File original copies and maintain physical archives.
- Ensure electronic copies are saved in the vendor file and Quality Agreement Folder.

**Internal Audits**
- Loading of findings on Trackwise, tracking and following up on Open and overdue actions
- Assist with auditor allocation.

**General QA administrative Support**
- Assist with Deviations, CAPAs, Change Controls and justifications.
- Maintain Vendor Quality Complaints and Vendor Change notification trackers.
- Compile weekly, monthly Quality slides for QA Vendors and assist QA Outsource with Quality Management Review preparations.
- Assist with maintaining the Quality and Change Notification Agreement register.
- Organizing and scheduling all ad-hoc/ recurring QA-related meetings/workshops/teleconferences.
- Photocopying and scanning of documentation.
- Overseeing all general QA department queries.
- Assist the Senior QA Officer and QA Officer with the gathering of information for communication purposes.

**_ Disclaimer: _**
- By submitting your CV and personal information, you agree that Biovac may utilise this information to conduct and complete our recruitment process, which entails distributing your information to all internal recruitment participants and service providers who forms part of the process._

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