QA Lead Auditor

MNA Recruitment (Pty) Ltd; Gauteng; On-site; ZAR 300,000 - 400,000; Full time

Job summary

A global pharmaceutical company is seeking a QA Lead Auditor to ensure compliance with regulatory authority expectations. The ideal candidate will have at least 5 years of experience in the pharmaceutical industry and a relevant science degree. Responsibilities include conducting audits, managing CAPAs, and providing support during inspections. This position offers an opportunity to contribute significantly within a robust quality management system.

Qualifications

• Minimum 5 years relevant experience in the pharmaceutical industry (Quality Assurance, Production, and Quality Control).
• Certified ISO Auditor or equivalent experience as a Lead Auditor in a GxP environment.
• Sound knowledge of GxP requirements and SAHPRA guidelines.

Responsibilities

• Ensure compliance with audit schedules and risk-based approach for inspections.
• Conduct quarterly trending of CAPAs from self-inspections.
• Communicate audit documentation timeously for critical outcomes.

Skills

Interpersonal skills

Problem solving analysis skills

Time management

Detail-oriented

Ability to work under pressure

Education

Relevant Science related degree

Tools

ISO Audit standards

Job description

Job Title

A global pharmaceutical company has a vacancy for a QA Lead Auditor.

Job Purpose

Job Purpose :

To ensure that the management of outsourced activities is undertaken in line with Regulatory Authority expectations and company Healthcare Group regulations and directives.

Main Duties and Responsibilities

• Ensure that an annual internal self-inspection schedule is signed off using a risk-based approach. Execute self-inspections within company operating organizations as per schedule.
• Conduct quarterly trending of CAPAs arising from self-inspections.
• Ensure that an annual audit schedule of all outsourced activities (GxP) is signed off using a risk-based approach. Execute all GxP audits as per schedule. Execute adhoc audits as per business needs.
• Reviews and approve appropriate Corrective Plans and Preventive Plans with GxP suppliers and follow-up on the completion of agreed CAPA’s within stipulated timelines.
• Ensure that all audit related documentation is communicated timeously, where Critical and Unacceptable Outcomes are identified, escalate the matters timeously to Head of Quality Assurance as per Escalation and Crisis Management procedure.
• Participate as applicable in the development of Internal Supplier Quality Process to ensure Compliance with Quality Management System.
• Provide relevant support to the company’s Market Authorization Holders and entities during regulatory, Corporate Quality Assurance and Principal inspections.
• Provide requisite information for monthly KPI reporting to Head of Quality Assurance. Provide information required for Quality Review Board meetings in relation to Management of Outsourced activities.
• Forwarding of all received Product Quality Complaints, Adverse Events and Medical Enquiries to the relevant person in Quality Assurance / Pharmacovigilance / Medical Affairs

Qualifications / Requirements

• Qualification – Relevant Science related degree
• Minimum 5 years relevant experience in pharmaceutical industry (Quality Assurance, Production and Quality Control).
• Certified ISO Auditor or equivalent experience as a Lead Auditor in a GxP environment
• Sound knowledge of the principles of GxP requirements and SAHPRA guidelines
• Embodies Values & Behaviours in all internal and external interactions.
• People skills – highly adapted interpersonal skills
• Problem solving analysis skills
• Priority setting – initiative and follow through
• Time management and deadline driver
• Ability to analyze complex data, seek relevant opinions
• Detail oriented
• Ability to work under pressure

Candidates that meet the criteria may apply via this portal or via www.mnarecruitment.com

Should you not receive feedback within 7 days, please accept your application as unsuccessful