Quality Systems and Training Lead

6 months 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 Systems and Training Lead to join a goal-oriented team.


**QUALIFICATIONS NEEDED**:

- Bachelor's degree or diploma in Microbiology/ Biotechnology, Pharmacy, or equivalent.
- Certification with Trackwise enterprise.

**NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE**:

- At least 5 years of experience in the vaccine/ biotech/ or pharmaceutical manufacturing industry of which at least 3 years of sterile manufacturing experience is required.
- At least 2-3 years of experience at the supervisory/management level in GMP Pharmaceutical manufacturing or equivalent
- Experience in quality and regulatory compliance within a cGMP facility
- Strong knowledge of sterile manufacturing environments.
- Experience in having faced successful local and international quality audits.
- Technical understanding of the Salesforce platform, Salesforce Infrastructure, and eQMS systems
- Working knowledge of Salesforce platform, Trackwise System, and system design including the use of process builders and flows
- Experience in Training within an Aseptic Manufacturing facility.

**KEY DUTIES & RESPONSIBILITIES OF THE ROLE**:

- Manage and maintain the TrackWise system, including user access, security configurations, and system settings.
- Customize workflows, forms, and templates to align with the organization's specific quality processes.
- Regularly update and optimize the system to enhance its usability and efficiency.
- Manage all Quality systems activities, planning to ensure that department goals are timeously obtained.
- Overall responsible for all systems within the PQS (Pharmaceutical Quality systems) including Deviations, CAPAs, Change Controls, Quality Risk Management and, DocMS, Logbook management, Archiving, Trackwise Management.
- Leads and participates in all QA engagement with external third-party stakeholders (e.g., Pfizer and Sanofi) where Quality systems are impacted.
- Coordinate and analyze all site metrics appropriate with the PQS and drive continuous improvement.
- Implements digital solutions to Quality processes as part of continuous improvement.
- Manage activities in the Document Control Centre related to providing required documentation and implementing and maintaining related documentation systems (DocMS, Archiving, SharePoint templates, Logbook management).
- Coordinate and analyze all site metrics appropriate with the PQS and drive continuous improvement.
- Lead the site management review and ensure that action plans are tracked and implemented.
- Leads and participates in all QA engagement with external third-party stakeholders (e.g., Pfizer and Sanofi) where Quality systems are impacted.
- Responsible for ensuring that site compliance metrics are achieved, and actively participates in driving site compliance.
- Leads all audit preparation activities on site.
- Review and lead all discussions around site metrics with the applicants.
- Provide technical guidance to QA Systems and the site team on the QMS processes.
- Drive continuous improvement on site.
- Responsible to keep up to date with cGMP and Guidelines. Ensure that this is updated within the site library.
- Ensures that obligations, as set out in the Quality agreements, are fulfilled during the QMS process.
- Review and approve documentation within defined timelines as stated in SOPs.
- Review and approve all Deviations, Change controls, Incidents, and CAPAs linked to the Quality system.
- Check the maintenance of the department, premises, and equipment to ensure optimal operation at all times.
- Oversee customer and regulator audits and ensure tracking and closure of findings, whilst maintaining appropriate communication between Biovac and auditors.
- Ensuring that the document control activities are achieved at the required quality levels (Biovac, SAHPRA, and WHO), within the agreed timeframe.
- Ensure proper management of archived documents.
- Supports the QA operations manager with key site projects.
- Ensures that scientific rationales, risk assessments, and reports are in place to support operations.
- Leads all QA digitalization projects.
- Lead significant investigations that can impact Quality Systems.
- Lead significant risk assessments in accordance with ICH Q9.
- Responsible for ensuring that the eQMS (Trackwise digital) is effectively maintained, updated to the latest cGMP requirements, and operational to support site activities.
- Leads all audit preparation activities within the QA departments on site.
- Review and lead all discussions around site metrics with the applicants.
- Responsible for ensuring that the eQMS (Trackwise digital) is effectively maintained, updated to the latest cGMP requirements, and operational to support site activities.
- Responsible for the Site GMP training program.
- Engages with internal

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