Quality Assurance Specialist - Pharmaceutical Operations

Placements24; Paarl; In loco; ZAR 420.000 - 640.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive salary

Medical benefits

Retirement benefits

Career development opportunities

Descrizione del lavoro

Placements24 in Paarl, Western Cape, is seeking a diligent Quality Assurance Specialist to ensure GMP-compliant manufacturing and distribution of pharmaceutical products, upholding safety, quality and regulatory standards.

You will conduct batch record reviews, manage deviations and CAPAs, oversee change control, and perform internal audits while supporting training and improvement across manufacturing and quality systems. Experience in GMP and QA within pharma is essential.

Competenze

• Bachelor's degree in Pharmacy, Chemistry, Microbiology or life sciences.
• Minimum 3 years of QA/QC experience in pharma.
• Strong understanding of GMP and regulatory guidelines.
• Experience with batch record review, deviation management and change control.
• Analytical and problem-solving skills with attention to detail.
• Excellent written and verbal English communication.
• Ability to work independently and in a team.
• Proficiency in Microsoft Office; familiarity with quality software is desirable.
• Pharma QA experience in Paarl, Western Cape is advantageous.

Mansioni

• Review and approve batch manufacturing records (BMRs) and documentation.
• Manage deviations, investigations, and CAPAs to address quality issues.
• Oversee the change control process and regulatory impact.
• Conduct internal audits of processes, systems and documents.
• Participate in external audits by regulators/customers.
• Develop and maintain SOPs and quality system docs.
• Provide QA support and training to manufacturing and operations.
• Monitor quality metrics and drive continuous improvement.
• Ensure compliance with GMP, GDP and pharmaceutical regulations.
• Manage product complaints and coordinate investigations.

Conoscenze

Analytical thinking

Problem-solving

Written communication (English)

Verbal communication (English)

Organizational skills

Independent work

Team collaboration

Formazione

Bachelor's degree in Pharmacy, Chemistry, Microbiology or life sciences

Strumenti

Microsoft Office

Quality management software

Descrizione del lavoro

About the Role

Our client, a reputable pharmaceutical company, is seeking a diligent and detail-oriented Quality Assurance Specialist to join their operations team in Paarl, Western Cape. This role is vital in ensuring that all pharmaceutical products manufactured and distributed by the company meet the higheststandards of quality, safety, and efficacy, in full compliance with regulatory requirements. The QA Specialist will be involved in a wide range of activities, including batch record review, deviation management, change control, and internal audits. The ideal candidate will possess a strong understanding of GMP principles and a meticulous approach to quality control. This position offers an excellent opportunity for professional growth within a company committed to excellence in healthcare. We provide a collaborative work environment in Paarl, Western Cape, that values integrity, accountability, and continuous improvement.

Key Responsibilities

• Review and approve batch manufacturing records (BMRs) and associated documentation to ensure compliance with established procedures and specifications.
• Manage deviations, investigations, and CAPAs (Corrective and Preventive Actions) to address quality issues effectively.
• Oversee the change control process, assessing the impact of proposed changes on product quality and regulatory compliance.
• Conduct internal audits of manufacturing processes, quality systems, and documentation to identify areas for improvement.
• Participate in external audits by regulatory agencies and customers.
• Develop and maintain Standard Operating Procedures (SOPs) and other quality system documents.
• Provide QA support and training to manufacturing and other operational departments.
• Monitor key quality metrics and contribute to continuous improvement initiatives.
• Ensure compliance with GMP, GDP, and relevant pharmaceutical regulations.
• Manage product complaints and collaborate with relevant departments for investigation and resolution.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Microbiology, or a related life science discipline.
• Minimum of 3 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.
• Solid understanding of Good Manufacturing Practices (GMP) and other relevant regulatory guidelines.
• Experience with batch record review, deviation management, and change control procedures.
• Strong analytical and problem-solving skills with keen attention to detail.
• Excellent written and verbal communication skills in English.
• Ability to work independently and collaboratively within a team.
• Proficiency in Microsoft Office Suite and familiarity with quality management software is desirable.
• Experience in a Paarl, Western Cape pharmaceutical setting is advantageous.
• Strong organizational skills and the ability to manage multiple tasks efficiently.

Benefits

• Our client offers a competitive salary, comprehensive medical and retirement benefits, and opportunities for professional development and career advancement.
• Join our dedicated team in Paarl, Western Cape, and contribute to the quality and safety of essential pharmaceutical products.
• We foster a supportive and dynamic work environment where your contributions are recognized and valued, providing a platform for sustained career growth.