Job Description

Position Summary:

Eve Oils is seeking a qualified and experienced Quality Assurance Manager (QAM) to lead and manage all quality-related functions within our pharmaceutical-grade extraction and manufacturing facility. The QAM will work closely with the Responsible Pharmacist (RP) and senior management to ensure that all manufacturing processes and outputs meet internal standards and comply with all applicable regulatory and GMP requirements.

Key Responsibilities:

1. Quality Management System (QMS):

Establish, implement, and maintain the QMS in accordance with SAHPRA, SAPC, and GMP guidelines.

Develop, approve, and maintain Standard Operating Procedures (SOPs), forms, and documentation.

Oversee and manage deviations, change controls, and corrective and preventive actions (CAPAs).

Ensure document control, versioning, and regulatory compliance of all quality documents.

2. Regulatory Compliance & Audits:

Ensure compliance with relevant regulatory bodies including SAHPRA, DOH, SAPC, and PIC/S standards.

Prepare for and lead internal and external GMP audits, including vendor audits and regulatory inspections.

Support the RP in maintaining facility licensure and audit readiness.

Maintain current awareness of applicable regulations and GMP updates.

3. Material and Product Quality Oversight:

Approve or reject starting materials, packaging materials, intermediates, bulk, and finished products.

Review and evaluate batch manufacturing records for release.

Ensure all quality control testing is completed according to validated methods and approved specifications.

Manage product complaints, recalls, rejections, and returns in collaboration with the RP.

4. Validation and Qualification:

Participate in the planning, execution, and review of qualification and validation activities (IQ/OQ/PQ).

Approve and oversee equipment, utility, and process validation protocols and reports.

Manage stability testing programs and sample retention procedures.

5. Training and Personnel Development:

Develop, implement, and maintain GMP and quality training programs for QA and site personnel.

Ensure competency and qualification of QA staff through training records and ongoing development.

Support cross-departmental training on hygiene, documentation, and quality procedures.

6. Leadership and Cross-Functional Support:

Provide quality oversight across production, QC laboratory, warehouse, utilities, and facility functions.

Act as part of the site leadership team in decision-making processes affecting product quality.

Attend and contribute to management review meetings.

Collaborate with the Production Manager and RP on shared responsibilities such as process validation, hygiene monitoring, and storage conditions.

Qualifications and Experience:

Bachelor's degree in Pharmaceutical Sciences, Biotechnology, Chemistry, or a related field.

Minimum 2 years' experience in a GMP pharmaceutical manufacturing environment.

Experience in botanical extraction facilities is highly desirable.

Must be a registered pharmacist with the South African Pharmacy Council (SAPC).

Strong understanding of local and international pharmaceutical regulatory requirements (e.g., SAHPRA, ICH Q7, PIC/S). Working knowledge of EU-GMP guidelines and expectations is required.

Proven ability to manage quality teams and GMP systems effectively.

Key Competencies:

Strong leadership and communication skills.

Detailed knowledge of GMP, GACP, SAHPRA, and SAPC requirements.

Proficiency in CAPA management, root cause analysis, and documentation review.

Excellent organizational and analytical thinking.

Key Performance Indicators (KPIs):

Timely and compliant closure of quality events (deviations, CAPAs, changes).

Successful completion of audits and inspections.

Staff training compliance rate.

Documentation accuracy and process adherence.

Work Conditions:

Full-time position located at Eve Oils manufacturing site.

Must be available for regulatory inspections and audit support when required.

Will act as the Deputy Responsible Pharmacist during the RP's absence, as per company delegation.

Job Types: Full-time, Permanent

Work Location: In person