Assistant Quality Assurance Manager

Sagar Vitaceuticals Nigeria Limited (SVNL)

Sagar Vitaceuticals Nigeria Limited (SVNL) is a pharmaceutical manufacturing company based in Ikeja, Lagos. Originally established as a joint venture, it is now owned by Sagar Overseas Ltd. SVNL operates a modern facility with high-capacity production lines for tablets, capsules, ointments, and more, adhering to GMP standards.

The company is NAFDAC-approved and partners with Nigeria’s Federal Ministry of Health to support local drug production. Its product portfolio includes vitamins, antibiotics, and over-the-counter supplements.

We are recruiting to fill the position below:

Job Title: Assistant Quality Assurance Manager

Location: Ikeja, Lagos

Employment Type: Full-time

Department: Quality Assurance

Reports To: Quality Assurance Manager / Head of Quality Assurance

Job Purpose

• To support the Quality Assurance Manager in implementing, maintaining, monitoring, and continually improving the company’s Pharmaceutical Quality Management System (QMS) to ensure that all pharmaceutical products are manufactured, tested, stored, and distributed in compliance with applicable Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), regulatory requirements, and company quality standards.
• The Assistant Quality Assurance Manager will assist in maintaining product quality, ensuring regulatory compliance, managing quality-related risks, and promoting a culture of quality and continuous improvement throughout the organization.

Key Responsibilities and Duties

Quality Management System (QMS):

• Assist in the implementation, maintenance, and continuous improvement of the company’s Quality Management System.
• Review, update, and control Standard Operating Procedures (SOPs), specifications, quality manuals, forms, and other controlled documents.
• Monitor compliance with approved procedures, quality policies, and applicable regulatory requirements.
• Support the preparation of quality performance reports and management review meetings.
• Ensure effective implementation of change control, deviation management, corrective and preventive actions (CAPA), and risk management systems.

Good Manufacturing Practices (GMP) Compliance:

• Monitor compliance with applicable GMP requirements across production, quality control, warehousing, engineering, and other relevant departments.
• Conduct routine GMP inspections of manufacturing areas, warehouses, utilities, and personnel practices.
• Ensure that manufacturing and quality records are completed accurately, contemporaneously, and in accordance with Good Documentation Practices.
• Identify quality and compliance gaps and recommend appropriate corrective actions.
• Promote adherence to data integrity principles and applicable ALCOA+ expectations.

Batch Documentation and Product Release Support:

• Review batch manufacturing records, batch packaging records, and associated quality documentation for completeness, accuracy, and compliance.
• Verify that deviations, discrepancies, and other quality issues are appropriately documented and investigated.
• Ensure that identified documentation errors and non-conformances are resolved through approved procedures.
• Support the Quality Assurance Manager in batch disposition and release activities, where formally authorized.
• Ensure that products are not released or distributed without the required quality approvals.

Deviations, Investigations, and CAPA:

• Coordinate the documentation and investigation of deviations, non-conformances, complaints, and quality incidents.
• Assist in root cause analysis and risk assessment.
• Track CAPA implementation and verify the effectiveness of corrective and preventive actions.
• Identify recurring quality issues and recommend preventive measures.
• Escalate critical quality issues and potential product-quality risks to the Quality Assurance Manager.

Audits and Regulatory Inspections:

• Assist in planning and conducting internal GMP audits and self-inspections.
• Participate in supplier, contract manufacturer, and other external quality audits as assigned.
• Coordinate the preparation of audit documents and evidence for regulatory inspections.
• Track audit observations, corrective actions, and closure timelines.
• Support compliance with applicable requirements of NAFDAC and other relevant national or international regulatory authorities.

Validation and Qualification:

• Support the review and approval process for validation and qualification protocols and reports, as authorized.
• Monitor compliance with equipment qualification, process validation, cleaning validation, and computerized system validation requirements, as applicable.
• Ensure that validation activities are appropriately documented and deviations are addressed.
• Support periodic review of validated processes and systems.

Quality Control and Laboratory Oversight:

• Work collaboratively with the Quality Control department to ensure adherence to approved specifications, test methods, sampling procedures, and laboratory controls.
• Monitor the investigation and documentation of out-of-specification (OOS) and out-of-trend (OOT) results.
• Ensure that quality concerns are escalated and resolved in accordance with approved procedures.
• Support the review of laboratory documentation and analytical data, within the scope of the Quality Assurance function.

Supplier Quality and Materials Management:

• Assist in the qualification and periodic evaluation of suppliers and service providers.
• Support the review of supplier documentation, certificates of analysis, and material quality records.
• Monitor the handling of rejected, quarantined, returned, and recalled materials or products.
• Ensure that quality concerns involving raw materials, packaging materials, and finished products are appropriately investigated and documented.

Product Complaints and Recalls:

• Assist in the investigation and documentation of product quality complaints.
• Support product recall and mock recall exercises.
• Ensure that complaint trends are reviewed and significant risks are escalated promptly.
• Assist in the preparation of investigation reports and regulatory notifications where required.

Training and Personnel Development:

• Identify GMP and quality training needs in collaboration with relevant department heads.
• Assist in preparing and delivering training on SOPs, GMP, documentation practices, and quality procedures.
• Monitor training completion and maintain appropriate training records.
• Promote quality awareness, accountability, and continuous improvement across the organization.

Team Coordination and Reporting:

• Supervise or coordinate assigned Quality Assurance personnel as delegated.
• Assist in allocating daily QA activities and monitoring completion of assigned tasks.
• Prepare periodic reports on deviations, CAPA, audits, documentation compliance, complaints, and other quality indicators.
• Perform other quality-related duties assigned by the Quality Assurance Manager.

Key Performance Indicators (KPIs)

Performance will be evaluated using relevant, risk-based indicators, including:

• Timely closure of deviations and CAPA within approved timelines.
• Effectiveness of CAPA implementation.
• Compliance with internal audit schedules and timely closure of audit findings.
• Batch record review accuracy and turnaround time.
• Percentage of current, approved SOPs and completed training records.
• Reduction in recurring deviations and documentation errors.
• Timeliness of complaint investigations and recall readiness.
• Compliance with applicable GMP and regulatory requirements.
• Timely escalation and resolution of critical quality issues.

Educational Qualifications

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biochemistry, Microbiology, Industrial Chemistry, or another relevant science discipline.
• A Master’s degree or relevant postgraduate qualification in Quality Assurance, Pharmaceutical Quality Management, or a related field is an advantage.
• Professional registration with the relevant regulatory or professional body is required where applicable to the candidate’s discipline and responsibilities.

Work Experience:

• Minimum of 3–5 years of relevant experience in pharmaceutical manufacturing, quality assurance, quality control, or pharmaceutical quality management.
• Demonstrated experience in GMP compliance, SOP management, deviation investigations, CAPA, internal audits, and batch documentation review.
• Experience supporting regulatory inspections and pharmaceutical quality systems is an advantage.
• Previous supervisory experience is desirable.

Required Knowledge and Skills:

• Sound knowledge of applicable GMP requirements and pharmaceutical quality systems.
• Understanding of NAFDAC requirements and other relevant regulatory standards.
• Knowledge of GDP, data integrity, risk manag