Quality Assurance Specialist (Pharmaceuticals)

Placements24; Soweto; Hybrid; ZAR 650,000 - 900,000; Full time

Benefits offered by this job

Competitive salary with performanceBon

Medical insurance

Retirement annuity

Generous annual leave

Professional development opportunities

Job summary

Placements24 is seeking a Quality Assurance Specialist for a reputable pharmaceutical manufacturer in Soweto, Gauteng. The role focuses on ensuring all manufacturing processes and products meet GMP and other regulatory standards, reviewing documentation, conducting internal audits, and supporting the quality management system.

The ideal candidate will have a life science degree, at least 3 years in QA/QC, strong analytical skills, experience with deviations and change control, and proficiency in

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Microbiology, or related life science field.
• Minimum 3 years experience in Quality Assurance or Quality Control within the pharmaceutical industry.
• Thorough understanding of cGMP regulations and pharmaceutical quality systems.
• Experience with batch record review, deviation investigations, and change control processes.
• Proficiency in documentation management and audit processes.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication abilities.
• High attention to detail and accuracy.
• Ability to work effectively in a team and independently.

Responsibilities

• Review and approve manufacturing batch records and associated documentation.
• Conduct internal audits of manufacturing processes, quality control procedures, and documentation.
• Investigate deviations, non-conformances, and out-of-specification (OOS) results, recommending and implementing corrective actions.
• Participate in the validation of equipment, processes, and analytical methods.
• Develop and revise Standard Operating Procedures (SOPs) related to quality assurance.
• Ensure compliance with current Good Manufacturing Practices (cGMP) and other regulatory requirements.
• Support regulatory inspections and customer audits.
• Maintain quality documentation and ensure its proper storage and retrieval.
• Contribute to risk assessment activities and quality improvement initiatives.
• Provide training to personnel on quality assurance principles and procedures.

Skills

cGMP knowledge

Documentation management

Internal audits

Deviation investigations

Change control

Microsoft Office Suite

Analytical skills

Communication skills

Teamwork / independent work

Education

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

Tools

Microsoft Office Suite

Job description

About the Role

Our client, a highly reputable pharmaceutical manufacturer, is actively seeking a dedicated Quality Assurance Specialist to join their team in Soweto, Gauteng . This critical role will ensure that all manufacturing processes and products comply with stringent regulatory standards, including Good Manufacturing Practices (GMP) and other relevant pharmaceutical guidelines. The QA Specialist will be responsible for reviewing documentation, conducting internal audits, investigating deviations, and contributing to the overall quality management system. The ideal candidate will possess a strong understanding of pharmaceutical quality principles and a meticulous approach to detail.

Key Responsibilities

• Review and approve manufacturing batch records and associated documentation.
• Conduct internal audits of manufacturing processes, quality control procedures, and documentation.
• Investigate deviations, non-conformances, and out-of-specification (OOS) results, recommending and implementing corrective actions.
• Participate in the validation of equipment, processes, and analytical methods.
• Develop and revise Standard Operating Procedures (SOPs) related to quality assurance.
• Ensure compliance with current Good Manufacturing Practices (cGMP) and other regulatory requirements.
• Support regulatory inspections and customer audits.
• Maintain quality documentation and ensure its proper storage and retrieval.
• Contribute to risk assessment activities and quality improvement initiatives.
• Provide training to personnel on quality assurance principles and procedures.

Requirements

• A Bachelor's degree in Pharmacy, Chemistry, Microbiology, or a related life science field.
• A minimum of 3 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.
• Thorough understanding of cGMP regulations and pharmaceutical quality systems.
• Experience with batch record review, deviation investigations, and change control processes.
• Proficiency in documentation management and audit processes.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication abilities.
• High attention to detail and accuracy.
• Ability to work effectively in a team and independently.
• Proficiency in Microsoft Office Suite.

Benefits

• Our client offers a competitive annual salary, complemented by performance-based bonuses.
• Benefits include comprehensive medical insurance, a retirement annuity, and generous annual leave.
• The company is committed to professional development and provides opportunities for advanced training and career growth within its quality and compliance departments.
• This role is located in Soweto, Gauteng , offering a challenging and rewarding career in the vital pharmaceutical manufacturing sector.