Quality Assurance Specialist - Pharmaceutical Operations

Placements24; Mossel Bay; On-site; ZAR 650,000 - 900,000; Full time

Benefits offered by this job

Relocation assistance

Medical aid

Retirement plan

Career development

Competitive salary with incentives

Job summary

Placements24 in Mossel Bay, Western Cape, seeks a meticulous Quality Assurance Specialist to oversee and enhance quality systems at our pharmaceutical facility. This on-site role ensures products meet stringent regulatory standards through audits, documentation review, deviation management, and continuous improvement initiatives.

You will maintain QMS in line with GMP and ICH guidelines, review batch records, manage CAPAs, and train staff on GMP principles, contributing to product safety and

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Microbiology, or related life science.
• Minimum of 4 years of QA experience within the pharmaceutical industry.
• Knowledge of GMP, ICH guidelines and regulatory requirements (e.g., SAHPRA).
• Proven experience in audits, deviations and CAPAs.
• Strong understanding of pharmaceutical manufacturing processes.
• Attention to detail and analytical skills.
• Proficiency in QA software and documentation practices.
• Excellent communication and stakeholder influence abilities.

Responsibilities

• Develop, implement, and maintain QMS in line with GMP and other regulatory standards.
• Conduct internal audits and participate in external audits by regulators and customers.
• Review and approve batch records, validation protocols, and quality documents.
• Manage deviations, CAPAs, and change control processes.
• Ensure compliance with manufacturing processes and product specs.
• Train personnel on quality procedures and GMP principles.
• Monitor quality indicators and drive continuous improvement projects.
• Serve as primary contact for quality inquiries across departments and external bodies.

Skills

GMP knowledge

ICH guidelines

Auditing

CAPA management

QMS implementation

Documentation

Regulatory compliance

QA communication

Education

Bachelor's degree in Pharmacy, Chemistry, Microbiology or related life science

Tools

Quality management software

Job description

About the Role

Our client, a prominent pharmaceutical company, is seeking a meticulous and experienced Quality Assurance Specialist to oversee and enhance quality systems at their facility in Mossel Bay, Western Cape . This role is critical in ensuring that all pharmaceutical products manufactured meet the highest standards of quality, safety, and efficacy, in strict accordance with national and international regulatory requirements. The QA Specialist will be responsible for audits, documentation review, deviation management, and continuous improvement initiatives. This is a key on-site role within a beautiful coastal setting, contributing to the company's commitment to excellence in pharmaceutical production.

Key Responsibilities

• Develop, implement, and maintain quality management systems (QMS) in line with GMP and other relevant regulatory standards.


• Conduct internal audits and participate in external audits by regulatory agencies and customers.


• Review and approve batch records, validation protocols, and other critical quality documentation.


• Manage deviations, CAPAs (Corrective and Preventive Actions), and change control processes.


• Ensure compliance with pharmaceutical manufacturing processes, product specifications, and regulatory guidelines.


• Train personnel on quality procedures and GMP principles.


• Monitor key quality indicators and implement continuous improvement projects.


• Act as a primary point of contact for quality-related inquiries from other departments and external bodies.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Microbiology, or a related life science discipline.


• Minimum of 4 years of progressive experience in Quality Assurance within the pharmaceutical industry.


• Comprehensive knowledge of GMP, ICH guidelines, and regulatory requirements (e.g., SAHPRA).


• Proven experience in conducting audits, managing deviations, and implementing CAPAs.


• Strong understanding of pharmaceutical manufacturing processes.


• Excellent attention to detail and analytical skills.


• Proficiency in quality management software and documentation practices.


• Effective communication and interpersonal skills, with the ability to influence stakeholders.


• Ability to work independently and as part of a collaborative team in Mossel Bay, Western Cape .

Benefits

• Competitive annual salary with performance-related incentives.


• Comprehensive medical aid and retirement plan.


• Relocation assistance may be available.


• Opportunities for professional development and career advancement.


• Contribution to a company dedicated to producing high-quality pharmaceuticals.


• Stable employment in a growing sector.