Quality Assurance Manager (Bpharm Req.) Gmp, Iso 9001, & Pharma Manufacturing Exp. Req

Specialist Search Recruitment; Gauteng; On-site; ZAR 1 000 000; Full time

Job summary

A leading pharmaceutical manufacturing company is seeking an experienced QA Manager with a background in pharma manufacturing. This role focuses on overseeing the Quality Management System (QMS) to ensure compliance with ISO standards and preparing for GMP regulatory requirements. Candidates should have a Bachelor's degree in Pharmacy and 4-5 years of QA experience. Competitive salary package with incentives offered.

Benefits

Pleasant annual bonus

Qualifications

• Minimum 4 to 5 years’ experience in QA within pharmaceutical, veterinary, or related manufacturing.
• Experience with regulatory audits and international quality standards.
• Strong knowledge of ISO and GMP principles.

Responsibilities

• Maintain, monitor, and improve the QMS, ensuring alignment with current regulatory expectations.
• Manage deviation handling, CAPA implementation, and change control processes.
• Conduct internal audits and vendor assessments as well as preparing for external regulatory inspections.
• Provide ongoing training to departments on quality aspects and future GMP requirements.

Skills

Quality Management System (QMS)

ISO standards

Regulatory compliance

Continuous improvement

Pharma manufacturing

Education

Bachelor's degree in Pharmacy

Job description

Introduction

A leading pharmaceutical manufacturing company, with some products that are Number 1 in the world, has an opportunity for an experienced QA Manager who has a pharma manufacturing background. In particular, this division of the company will be manufacturing animal health–related products. Experience in human health or animal health product manufacturing is fine. The Quality Assurance Manager is responsible for overseeing and maintaining the Quality Management System (QMS) to ensure compliance with ISO standards. In particular, you will be responsible for preparing this division of the business for future GMP regulatory requirements and GMP audits and certification. This role supports the manufacture of animal health products for both domestic and international markets, with a strong focus on continuous improvement, regulatory compliance & readiness, and quality culture. Experience in either pharmaceutical human health products or animal health veterinary products manufacturing is a requirement. The QA Manager position has the possibility of growing into a Responsible Pharmacist position in the future. No previous management experience is required.

Duties & Responsibilities

• Maintain, monitor, and improve the QMS, ensuring alignment with current regulatory expectations.
• Manage deviation handling, CAPA implementation, and change control processes.
• Trend deviations, CAPAs and change control.
• Assist in writing annual reports.
• Conduct internal audits and vendor assessments as well as preparing for external regulatory inspections.
• Ensure all operations comply with ISO (GMP where applicable) standards and site SOPs.
• Approve and control Quality documentation, including master batch records, SOPs, and validation/qualification protocols and reports.
• Provide training and support to departments on quality and compliance.
• Review and approve quality records, analytical results, and certificates of analysis relating to raw materials and packaging materials.
• Release raw materials and packaging materials.
• Implement a system for packaging materials testing and release.
• Control product quality artwork (product labels, release labels, etc.).
• Review and approve batch records, analytical results, and certificates of analysis for product release.
• Make quality decisions regarding batch release.
• Investigate product quality issues and lead root cause analysis.
• Lead complaint investigations.
• Manage product recalls and investigations.
• Qualify and monitor suppliers to ensure material quality.
• Conduct supplier risk assessments and maintain supplier compliance records.
• Assist in writing, reviewing and approval of qualification and validation protocols, including equipment, cleaning validation, process validation, method validations etc.
• Assist in preparing the business for GMP implementation and future regulatory inspections.
• Conduct and review risk assessments related to quality systems and product integrity.
• Provide ongoing training to departments on quality aspects and future GMP requirements.
• Implement processes to improve compliance and promote a culture of quality.
• Mentor QA team members and collaborate across departments.
• Assist in writing, reviewing and approving stability protocol and reports.
• Support shelf life extension decisions based on stability outcomes.
• Perform annual product reviews in line with regulatory expectations.
• Ensure compliance with applicable regulatory requirements for current and future markets.
• Prepare documentation and systems to support product registration and export readiness.

Desired Experience & Qualification

• Bachelor's degree in Pharmacy – required.
• Minimum 4 to 5 years’ experience in QA within pharmaceutical, veterinary, or related manufacturing.
• Pharma manufacturing experience is a requirement.
• Strong knowledge of ISO and GMP principles (SAHPRA, ICH, PIC/s and WHO).
• Strong knowledge of Act 36 and Act Experience with regulatory audits and international quality standards.

Package & Remuneration

Salary is negotiable to ensure we attract top‑level candidates. Salary may be influenced by specific experience, qualifications and a manufacturing background. A salary range of around 80, per month cost to company, pleasant annual bonus is envisaged for this role. (About R1 million+ per annum, plus an incentive bonus).

Interested?