Pharma QA Manager - Lead QMS, Audits & CAPA (On-Site)

Placements24; Centurion; On-site; ZAR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Performance bonus

Health insurance

Pension

Paid time off

On-site facilities

Job summary

Placements24 in Centurion seeks a meticulous and experienced Pharmaceutical Quality Assurance Manager to lead quality operations on-site. You will implement and maintain a robust QMS, conduct audits, oversee CAPA, and ensure compliance with GMP, FDA, EMA, and international guidelines.

You will manage and train the QA team, review batch records and validation protocols, and collaborate with regulatory affairs for inspections.

Qualifications

• Master's degree or PhD in Pharmacy, Chemistry, Biology, or related field.
• Minimum of 7 years of progressive experience in Pharmaceutical Quality Assurance and Quality Control.
• Extensive knowledge of cGMP, FDA, EMA, and other international guidelines.
• Experience managing QA teams and implementing QMS.
• Strong analytical and decision-making abilities.
• Understanding of manufacturing processes and equipment validation.

Responsibilities

• Develop, implement, and maintain the QMS in accordance with GMP and regulatory standards.
• Conduct internal and external audits of facilities, suppliers, and processes to ensure compliance.
• Manage and train the QA team, overseeing daily quality operations and adherence to procedures.
• Investigate deviations, non-conformances, and customer complaints, implementing CAPA.
• Review and approve batch records, validation protocols, and other critical quality documents.
• Collaborate with regulatory affairs to prepare for regulatory inspections.

Skills

QA leadership

Audit management

CAPA

Regulatory knowledge

Process validation

Education

Master's degree or PhD in Pharmacy, Chemistry, Biology, or related field

Job description

Placements24 in Centurion seeks a meticulous and experienced Pharmaceutical Quality Assurance Manager to lead quality operations on-site. You will implement and maintain a robust QMS, conduct audits, oversee CAPA, and ensure compliance with GMP, FDA, EMA, and international guidelines.

You will manage and train the QA team, review batch records and validation protocols, and collaborate with regulatory affairs for inspections.