Quality Assurance Auditor

2 weeks ago

Midrand, Gauteng, South Africa MSD Full time

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.

Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.


Primary responsibility:

  • Ensure preparation of annual audit schedule, using riskbased approaches and incorporating the global auditing topics.
  • Schedule and perform assigned audits for site program.
  • Ensure timelines and quality of content for audit execution (audit prework, conducting audit, issuance of audit report, CAPA review and verification) meet established expectations.
  • Review, and approve Audit Reports
  • Actively monitor, report and trend observations/CAPAs, along with standard site audit metrics to Quality Council and Management
  • Function as a change agent related to culture and audit program performance
  • Lead change and process improvement initiatives related to Auditing, Inspections, CAPA, and other compliance topics
  • Perform routine risk communications pertaining to audits/inspection to Site, Regional, and Divisional Management
  • Actively participate and take a leadership role in the Auditor Community of Practice and Guest Auditor Program
  • Review and ensure CAPA responses to Audits and Inspections are robust
  • Perform a riskbased verification and effectiveness check on key CAPAs from audits and inspections.
  • Recommend and lead implementation of improvements to the Audit and Inspection Management programs based on new regulations, guidance documents, and industry standards.
  • Lead site preparation activities for regulatory, our Company global and customer inspections.
  • Provide compliance advice to site, development and commercial product teams.
  • Supports and continually enhance the ongoing site Permanent Inspection Readiness status.
  • Achieve and maintain auditor qualification status through robust training and continuing education.
  • Lead training/orientation for new Quality Auditing staff.
  • Mentor new auditors to ensure comprehensive training and full understanding of auditor roles and responsibilities.
  • Perform, lead, and mentor other auditors during site audits; participate in opportunities to audit at regional sites.
  • Obtain and maintain cuttingedge knowledge and auditing techniques across applicable technical/Quality topics.
  • Contribute to Quality Council and ensures monthly metrics are supplied
  • Participates in Lean activities.
  • Ensures that safety rules are adhered to and that the Safety SOPs are maintained and followed.
  • Responsible for reporting adverse experiences or events (AEs), adverse device events (ADEs), product quality complaints (PQCs) and other reportable information, customer feedback (CF), alleged counterfeiting, diversion and tampering (CDT) that you become aware of to the Designated Point of Contact (DPOC).
  • Responsible for auditing status and audit requirements of local suppliers on Supplier Transparency and arranging audits with the global auditing body.
  • Responsible for the oversight and management of the Supplier / External Entity chapter for the site and act as Topic lead.

Qualifications/ skills

  • Minimum tertiary degree in Science, Pharmacy or equivalent.
  • Strong knowledge of pharmaceutical Good Manufacturing Practices, local and global regulatory requirements.
  • Strong understanding of Health Authority requirements i.e., SAHPRA and where the company is the Market Authorisation Holder.
  • Problem solving skills.
  • Able to deal with situations requiring interpretative and evaluative thinking.
  • Able to make unbiased and honest judgements.
  • Excellent people leadership and mentorship skills.
  • Proficiency in use of Microsoft Word, Excel software, Power Point
  • Ability to work independently with limited supervision
  • Ability to build relationships and influence across disciplines and all levels
  • Teamwork skills and flexibility
  • Takes initiative
  • Good oral and written communication essential

Experience required

  • Minimum of 35 years of quality operations, manufacturing, technology and/or laboratory experience within Good Manufacturing Practice environment
  • Advanced understanding of Good Manufacturing Practice particularly with reference to packaging operations.
  • Advanced understanding and knowledge of global regulatory requirements.
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide.

Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high quality, reliable supply to customers and patients on time, every time.


Who we are
We are known as Merck

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