Quality Assurance (QA) Officer

Sagar Vitaceuticals Nigeria Limited

We are recruiting to fill the position below:

Job Title: Quality Assurance (QA) Officer

Location: Makun City, Ogun

Employment Type: Full-time

Department: Quality Assurance

Reports To: Assistant Quality Assurance Manager / Quality Assurance Manager

Job Purpose

• To support the implementation and maintenance of the company's Pharmaceutical Quality Management System (QMS) and ensure that pharmaceutical manufacturing, packaging, storage, documentation, and other relevant operations comply with approved Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), applicable regulatory requirements, and company quality standards.
• The QA Officer is responsible for routine quality monitoring, documentation review, compliance checks, deviation reporting, and supporting activities that ensure the quality, safety, efficacy, and consistency of pharmaceutical products.

Key Responsibilities and Duties

GMP Compliance and Quality Monitoring:

• Monitor production, packaging, warehouse, and other designated areas for compliance with approved GMP requirements.
• Conduct routine GMP inspections and report identified deficiencies to the QA Supervisor or Manager.
• Verify personnel hygiene, gowning practices, environmental conditions, and housekeeping in designated production areas.
• Ensure that manufacturing and packaging activities are performed in accordance with approved procedures and batch documentation.
• Monitor compliance with contamination prevention, cross-contamination control, and material segregation requirements.
• Report critical quality risks and non-compliance promptly.

Batch Manufacturing and Packaging Documentation:

• Review batch manufacturing records (BMRs) and batch packaging records (BPRs) for completeness, accuracy, and compliance with approved instructions.
• Verify that entries are legible, traceable, contemporaneous, and properly authorized.
• Check that material quantities, batch numbers, equipment identification, process parameters, yields, and reconciliation records are appropriately documented.
• Identify documentation errors, discrepancies, and omissions and ensure they are addressed through approved procedures.
• Verify that required in-process checks and quality approvals have been documented.
• Escalate significant discrepancies before the affected batch proceeds to the next stage or is considered for release.

Line Clearance and In-Process Quality Assurance:

• Perform and document line clearance before manufacturing, packaging, and product changeover activities, as assigned.
• Verify removal of materials, labels, documents, and remnants from previous operations.
• Confirm the identity and status of materials, products, equipment, and packaging components before use.
• Conduct routine in-process QA checks according to approved SOPs and batch instructions.
• Verify compliance with approved process parameters and packaging requirements.
• Identify and report mix-ups, defects, deviations, and other quality concerns.
• Ensure that production activities proceed only after required checks and approvals have been completed.

Quality Management System (QMS):

• Assist in preparing, reviewing, issuing, and controlling SOPs, forms, specifications, and other controlled documents.
• Maintain document control registers and ensure obsolete documents are withdrawn from use.
• Support the documentation and investigation of deviations, non-conformances, and quality incidents.
• Assist in tracking corrective and preventive actions (CAPA) to completion.
• Participate in change control, risk assessment, and continuous improvement activities as assigned.
• Maintain accurate and retrievable QA records.

Deviations, CAPA, and Non-Conformance Management:

• Identify, document, and report deviations from approved procedures and established quality requirements.
• Assist in preliminary investigations and the collection of relevant evidence.
• Support root cause analysis and the implementation of corrective and preventive actions.
• Monitor assigned action items and escalate overdue or ineffective actions.
• Ensure that non-conforming materials and products are appropriately identified, segregated, and controlled.
• Report recurring deviations and emerging quality trends to the QA Manager.

Equipment, Cleaning, and Validation Compliance:

• Verify that equipment cleaning records and equipment status labels are completed appropriately.
• Monitor compliance with approved cleaning procedures and changeover requirements.
• Check that relevant equipment calibration and qualification statuses are current before use, where applicable.
• Assist in reviewing validation and qualification protocols, reports, and records as assigned.
• Report equipment or process conditions that may compromise product quality.
• Support the implementation of approved validation, revalidation, and periodic review activities.

Audits and Regulatory Compliance:

• Participate in internal GMP audits, self-inspections, and departmental compliance assessments.
• Assist in preparing documents and records for regulatory inspections and external audits.
• Follow up on audit observations and assigned corrective actions.
• Support compliance with applicable NAFDAC requirements and other relevant regulatory standards.
• Ensure that audit evidence and quality records are properly maintained and readily retrievable.

Complaints, Returns, and Recall Support:

• Assist in receiving, documenting, and investigating product quality complaints.
• Support the evaluation and documentation of returned products in accordance with approved procedures.
• Participate in product recall and mock recall exercises when assigned.
• Maintain complaint, return, and recall records as applicable.
• Escalate suspected product defects or potential patient-safety risks immediately.

Training and Continuous Improvement:

• Participate in GMP, GDP, data integrity, hygiene, and other relevant quality training.
• Assist in monitoring staff compliance with assigned training requirements.
• Promote adherence to approved procedures and a culture of quality throughout the organization.
• Identify opportunities to improve documentation accuracy, compliance, and operational efficiency.
• Perform other QA-related duties assigned by the QA Manager.

Key Performance Indicators (KPIs)

Performance will be assessed against relevant, risk-based indicators, including:

• Accuracy and completeness of batch record reviews.
• Timeliness of line clearance and routine QA inspections.
• Compliance with approved GMP procedures.
• Timely identification and escalation of deviations.
• Accuracy and retrieval of controlled documents and QA records.
• Timely follow-up of assigned CAPA and audit actions.
• Reduction in recurring documentation errors and avoidable non-conformances.
• Completion of assigned inspections, reviews, and reports within agreed timelines.
• Compliance with applicable safety, hygiene, and data integrity requirements.

Educational Qualifications

• Bachelor’s degree, HND, or relevant qualification in Pharmacy, Pharmaceutical Sciences, Microbiology, Biochemistry, Chemistry, or another relevant scientific discipline.
• Additional training in pharmaceutical Quality Assurance, GMP, auditing, or quality management systems is an advantage.
• Relevant professional registration is required where applicable to the candidate’s qualification and assigned responsibilities.

Work Experience:

• Minimum of 1–4years of relevant experience in pharmaceutical manufacturing, Quality Assurance, or a related quality function is preferred.
• Experience in batch documentation review, line clearance, GMP inspections, and deviation reporting is an advantage.
• Familiarity with pharmaceutical production and packaging operations is desirable.
• Entry-level candidates may be considered where structured training and supervision are available.

Required Knowledge and Skills:

• Good understanding of pharmaceutical GMP and GDP.
• Knowledge of SOP compliance, document control, batch records, line clearance, and contamination prevention.
• Basic understanding of deviations, CAPA, change control, and risk management.
• Knowledge of data integrity principles, including ALCOA+ expectations.
• Strong attention to deta