Contact Email: recruitment@obpvaccines.co.za
Closing Date: March 20, 2025
Ref: QAC14/2025
The Quality Assurance Officer: Compliance is responsible for implementing and maintaining the
quality management systems at OBP
Main Responsibilities include: * Manage, monitor and maintain the allocated Quality
Management system(s) (ensure numbers are issued according to procedure and a register is
in place, maintained and up to date) * Ensure all allocated Quality Management system
documentation is correctly completed, closed out, scanned and archived *Ensure compliance
to all applicable regulations and internal procedures by proactively interpreting regulatory and
quality requirements * Ensure that a Vendor management schedule is in place, monitor vendor
audits, and follow up on outstanding CAPA plans for close out * Participate in investigations of
quality related complaints and write reports where needed. * Monitor and report on developing
trends * Participate in the investigation of incidents, OOS, deviations, discrepancies, root cause
investigations or test failures as required * Support allocated operational area(s) of responsibility
in closure of non-conformances/deviations, change controls, CAPAs and investigations *Review
and approve Corrective Actions and Preventative Actions (CAPA) in order to meet compliance
requirements *Review and approve change controls for quality and regulatory compliance
impact and determine requirements for implementation *Perform QA checks of areas of
responsibility on a monthly basis and ensure that observations are documented and followed
up * Conduct internal audits on site as per assigned audit schedule *Ensure that area(s) of
responsibility are audit ready *Ensure audit readiness within own role through closing out audit
findings timeously *Support QA department with Regulatory audits and 3rd party audits * *
*Support other department functions pertaining to projects, other initiatives or cross
departmental work *Contribute towards the mitigation of the department’s risk profile by
implementing sound governance and compliance processes and tools to identify and manage
risks.
Minimum Requirements: * Degree in Microbiology / Biotechnology Pharmacy, Biological
Sciences or a similar field NQF 7 * ISO 9001 and/or cGMP auditing certification * Minimum 3
years’ experience in Quality Assurance within the pharmaceutical/ biotech manufacturing
industry *Experience in quality management systems within a cGMP facility is advantageous
*Quality and Regulatory compliance knowledge, i.e. SA GMP, PIC/S and WHO as well as
application.
Remuneration: A Paterson Grade C remuneration package will be offered that is
commensurate with experience and qualification of the successful candidate.
OBP reserves the right to fill any of its positions.
Suitably
qualified
candidates should submit their applications online at PNET
https://www.pnet.co.za. by the closing date. No late applications will be accepted or considered
after the closing date.
Only shortlisted candidates will be contacted.
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