Quality Assurance Auditor

SUMMARY:
a Big Giant within the Pharmaceutical Industry is looking to employ skillful Quality Assurance Auditor to join their dynamic team of experts urgently!!!

POSITION INFO:

Overview

Position: Quality Assurance Auditor

Salary: market related & negotiable

Location: Port Elizabeth

- Send detailed CV in Word Document, copy of Id, head and shoulders photo of yourself, pay slip, plus Qualifications urgently!!!!!!

Applicants are invited to apply for this excellent opportunity that exists for the above mentioned position. The successful incumbent will report to the QA Vendor Manager.

We encourage all suitable employees to apply.

Overview

• Approve local suppliers
• Monitor and support supplier-related activities and technical agreements
• Coordinate and execute internal and supplier audit programs
• Provide expert support to company and supplier sites to ensure successful regulatory inspections
• Continuous compliance of corporate and supplier audit programs
• Related administrative tasks

Responsibilities

Vendor Management

• Review and approve new suppliers
• Interpret, implement and maintain supplier technical agreements
• Build and maintain supplier relationships to ensure timely audits, effective communication, and to resolve deficiencies/ concerns
• Implement principles, processes and tools to manage suppliers
• Monitor compliance of supplier activities and contracts to GMP standards and technical agreements
• Monitor vendor performance to established performance metrics and communicate performance issues

 Vendor Audit Management

• Coordinate, schedule and conduct supplier and service provider audits to assess compliance
• Issue audit reports and follow up on responses to audit findings, including CAPA plans; close out supplier audits
• Perform due diligence visits/audits of potential new suppliers
• Provide recommendations on suitability and compliance of suppliers
• Propose follow-up remediation or CAPAs relevant to new suppliers

 Internal Audits Management

• Coordinate, schedule and conduct quality audits of company sites to assess compliance to GMP, MCC and international standards
• Conduct statutory internal audits as required by local authorities
• Prepare audit reports and review audit findings with unit managers
• Assist in audit investigations and provide input into CAPA plans
• Perform follow-up on unit actions plans and close out audits
• Prepare, update and review proposed changes to SOPs

 Governance, Risk & Compliance

• Provide input and evaluate changes to audit system to improve quality of audit
• Provide technical and regulatory guidance to internal and external stakeholders to ensure overall quality and compliance
• Ensure compliance of company and supplier audit programs

 Reporting

• Ensure timely input of data into the audit system

 Skills required

 Background/experience

• Bachelor’s degree in Science or Science-related field, with 4-6 years’ related experience or Post Graduate Degree
• Industry recognised audit qualification preferred
• Experience in GMP regulated industry in a QA and auditing role

 Specific job skills

• Excellent knowledge of good manufacturing regulations in Pharmaceutical industry
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives
• Ability to operate and audit within all global cultures
• Project management

 Competencies

• Information Gathering
• Interrogating Information
• Offering Insights
• Taking Action

NB! This job is now closed. You can apply for other jobs by uploading your CV.