Quality Assurance Specialist - Pharmaceutical Operations

Placements24; Stellenbosch; Hybrid; ZAR 360,000 - 600,000; Full time

Benefits offered by this job

Medical benefits

Retirement benefits

Professional development opportunities

Job summary

Placements24 has partnered with a reputable pharmaceutical company in Paarl, Western Cape, to recruit a diligent Quality Assurance Specialist. The role focuses on ensuring products meet quality, safety, and regulatory standards through batch record reviews, deviation management, change control, and internal audits.

The successful candidate will possess a Bachelor's degree in a life science, at least 3 years' QA/QC experience in pharma, and a strong GMP understanding.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Microbiology, or related life science.
• Minimum of 3 years in Quality Assurance/Quality Control in the pharmaceutical industry.
• Solid understanding of Good Manufacturing Practices (GMP) and other 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.

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.

Skills

QA in pharma

GMP knowledge

Batch record review

Deviation management

Change control

Auditing

English proficiency

MS Office

Quality management software

Education

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

Tools

Quality management software

MS Office Suite

Job description

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 highest standards 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.