Quality Assurance Specialist - Pharmaceutical Manufacturing

Placements24; Mossel Bay; Vor Ort; ZAR 420.000 - 720.000; Vollzeit

Benefits dieser Stelle

Competitive salary and benefits

Medical aid plan

Retirement fund contributions

Performance-based bonuses

Generous annual leave

Professional development opportunities

Zusammenfassung

Placements24 is seeking a meticulous Quality Assurance Specialist for a pharmaceutical manufacturing facility in Mossel Bay, Western Cape. The role ensures GMP-compliant processes and products, maintains regulatory readiness, and drives continuous improvement within a hands-on environment.

The ideal candidate has a Bachelor's degree in a scientific field and at least 4 years' QA/QC experience, with proven skills in batch-review, internal audits, CAPA, validation, and change control.

Qualifikationen

• Bachelor's degree in Pharmacy, Chemistry, Biology, or related scientific discipline.
• Minimum 4 years of QA/QC experience in pharmaceutical or medical device industry.
• Solid GMP, ICH guidelines and pharma quality systems knowledge.
• Experience reviewing batch records, internal audits, and CAPA management.
• Familiarity with validation principles and change control processes.
• Strong analytical and problem-solving skills with meticulous attention to detail.
• Excellent written and verbal communication skills.
• Ability to work independently and collaboratively within a team.
• Proficiency with MS Office and quality management software desirable.

Aufgaben

• Review and approve batch manufacturing records, ensuring adherence to procedures.
• Conduct internal audits of manufacturing processes, quality systems, and documentation.
• Investigate deviations, OOS results, and customer complaints, implementing CAPA.
• Participate in qualification and validation of equipment, processes, and analytical methods.
• Develop, revise, and implement SOPs and other quality-related documents.
• Monitor key quality indicators and participate in quality management review meetings.
• Manage change control processes, assessing impact on product quality and regulatory compliance.
• Support external regulatory inspections and audits with documentation and explanations.
• Train manufacturing personnel on GMP principles and quality system requirements.
• Release finished products after thorough review of all documentation and compliance checks.

Kenntnisse

GMP knowledge

CAPA experience

Internal audits

Batch record review

Quality systems

Analytical skills

Problem-solving

Documentation skills

Cross-functional collaboration

MS Office proficiency

Ausbildung

Bachelor's degree in Pharmacy

Bachelor's degree in Chemistry

Bachelor's degree in Biology

Tools

Quality management software

MS Office

Jobbeschreibung

About the Role

Our client, a well-established entity within the pharmaceutical manufacturing sector, is looking for a meticulous and experienced Quality Assurance Specialist . This critical role is based at their advanced facility in Mossel Bay, Western Cape . The QA Specialist will be instrumental in ensuring that all manufacturing processes and products consistently meet stringent quality standards and regulatory requirements, including Good Manufacturing Practices (GMP). You will play a key part in maintaining compliance, driving continuous improvement initiatives, and upholding the integrity of the company's operations. This position is perfect for a dedicated professional seeking to contribute to the quality and safety of pharmaceutical products in a hands-on manufacturing environment. Become a vital part of our quality-focused team in the beautiful region of Mossel Bay .

Key Responsibilities

• Review and approve batch manufacturing records, ensuring adherence to established procedures and specifications.
• Conduct internal audits of manufacturing processes, quality systems, and documentation to ensure compliance.
• Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPA).
• Participate in the qualification and validation of equipment, processes, and analytical methods.
• Develop, revise, and implement Standard Operating Procedures (SOPs) and other quality-related documents.
• Monitor key quality indicators (KQIs) and participate in quality management review meetings.
• Manage change control processes, assessing the impact of changes on product quality and regulatory compliance.
• Support external regulatory inspections and audits by providing necessary documentation and explanations.
• Train manufacturing personnel on GMP principles and quality system requirements.
• Release finished products after thorough review of all associated documentation and compliance checks.

Requirements

• A Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• A minimum of 4 years of experience in Quality Assurance or Quality Control within the pharmaceutical or medical device industry.
• Solid understanding of GMP regulations, ICH guidelines, and pharmaceutical quality systems.
• Experience in reviewing batch records, conducting internal audits, and managing CAPA.
• Familiarity with validation principles and change control processes.
• Strong analytical and problem-solving skills with meticulous attention to detail.
• Excellent written and verbal communication skills.
• Ability to work effectively both independently and collaboratively within a team.
• Proficiency in MS Office suite and experience with quality management software is desirable.

Benefits

• Our client offers a competitive salary and benefits package, including a comprehensive medical aid plan, retirement fund contributions, and performance-based bonuses.
• The role is based at a state-of-the-art facility in Mossel Bay, Western Cape , providing a stable and professional working environment.
• Opportunities for professional development and advanced training in quality management systems are provided.
• We value work-life balance and offer generous annual leave.
• Join a committed team dedicated to upholding the highest standards of pharmaceutical quality and safety.