Introduction:
Join a leading pharmaceutical company in Gauteng as a Quality Assurance Pharmacist. We are seeking a highly detail-oriented, analytical, and quality-focused Pharmacist with experience in pharmaceutical Quality Assurance, GMP compliance, and quality management systems. This is an excellent opportunity for a Pharmacist looking to develop or further their career within a pharmaceutical manufacturing and regulated industry environment.
Key Performance Areas:
- Ensure ongoing compliance with GMP, company quality standards, SOPs, and applicable regulatory requirements.
- Support and maintain the company’s Quality Management System (QMS) in accordance with pharmaceutical industry standards.
- Review and assess manufacturing and quality documentation to ensure accuracy, completeness, and compliance.
- Perform or support the investigation of deviations, non-conformances, complaints, and quality-related incidents.
- Assist with the development, implementation, tracking, and closure of Corrective and Preventive Actions (CAPA).
- Review and assess change controls to ensure appropriate quality and regulatory considerations are addressed.
- Participate in risk assessments and quality risk management activities.
- Review batch manufacturing and packaging documentation to ensure compliance with approved procedures and GMP requirements.
- Support batch release and product disposition activities, where applicable.
- Ensure that relevant SOPs, policies, protocols, and quality documentation are maintained, reviewed, and updated as required.
- Assist with the preparation for and participation in internal audits, customer audits, supplier audits, and regulatory inspections.
- Monitor and support the timely closure of audit findings, deviations, CAPAs, and other quality actions.
- Work closely with the Quality Control department to investigate out-of-specification results, out-of-trend results, and other laboratory-related quality concerns.
- Collaborate with Production, Quality Control, Regulatory Affairs, Engineering, Supply Chain, and other departments to ensure quality and GMP compliance.
- Support the implementation and monitoring of quality improvement initiatives.
- Ensure that all quality-related activities are appropriately documented and maintained in accordance with data integrity requirements.
- Assist with GMP training and quality awareness initiatives for relevant employees.
- Ensure compliance with applicable SAPC, SAHPRA, GMP, and pharmaceutical regulatory requirements.
- Maintain a high level of professional and ethical conduct in accordance with the responsibilities of a registered Pharmacist.
- Stay up to date with changes to pharmaceutical legislation, GMP requirements, regulatory guidelines, and industry best practices.
- Identify potential quality risks and proactively recommend appropriate corrective and preventative measures.
- Contribute to a strong quality culture and continuous improvement environment within the organisation.
Requirements:
Education & Registration:
- Pharm Degree or equivalent Pharmacy qualification.
- Registered with the South African Pharmacy Council (SAPC) as a Pharmacist.
- Current and valid SAPC registration is essential.
- Knowledge of pharmaceutical manufacturing and quality standards.
Experience & Skills:
- Minimum of 3–5 years’ experience in Quality Assurance within the pharmaceutical industry
- Previous experience within a pharmaceutical manufacturing, production, or regulated environment is highly advantageous.
- Strong knowledge and understanding of Good Manufacturing Practice (GMP) and pharmaceutical quality standards.
- Knowledge of Quality Management Systems (QMS) and pharmaceutical quality processes.
- Experience with deviations, CAPA, change controls, investigations, complaints, and quality documentation
- Understanding of batch documentation, batch review, and product release processes.
- Exposure to internal and external audits, regulatory inspections, and audit preparation
- Knowledge of South African pharmaceutical legislation and regulatory requirements.
- Strong understanding of SOPs, data integrity, risk management, and compliance requirements.
- Excellent attention to detail with strong analytical and problem-solving abilities.
- Strong communication and interpersonal skills.
- Ability to work effectively with Quality Control, Production, Regulatory Affairs, Supply Chain, and other cross-functional teams.
- Ability to work accurately and effectively within a highly regulated and deadline-driven pharmaceutical environment.
- Experience with SAP, ERP systems, or electronic Quality Management Systems
- Knowledge or experience in validation, qualification, and quality risk management
Note:
Only shortlisted candidates will be contacted and should you not hear from us within 2 weeks, please consider your application unsuccessful.
Tagged as: Pharmacist, QA Pharmacist, Quality Assurance Pharmacist, Quality Management System, SAPC