Quality Assurance Manager

Job Requirements

Education:

• Bachelor’s Degree or above in Pharmacy, Pharmaceutical Sciences, Chemistry, or with related field of study

• Additional training/certification in GMP, Quality Management Systems, validation, or regulatory affairs is an advantage.

Experience፡

• Minimum 5 years of relevant experience in pharmaceutical manufacturing, with substantial experience in Quality Assurance/Quality Control.

• Previous experience as a QA/QC Supervisor, Senior QA/QC Officer, or Manager is highly preferred.

• Experience working in a GMP-compliant pharmaceutical manufacturing facility is essential.

Quantity Required: 1

Salary: Negotiable

Duties and Responsibilities

• Establish, implement, and maintain the company’s Pharmaceutical Quality Management System (QMS) in accordance with GMP and applicable EFDA requirements.

• Ensure all manufacturing, packaging, testing, storage, and documentation activities comply with GMP and approved procedures.

• Develop, review, approve, and control SOPs, specifications, batch records, protocols, and other quality documents.

• Review and approve Batch Manufacturing Records (BMRs) and Batch Packaging Records before product release.

• Oversee the investigation and management of deviations, OOS/OOT results, complaints, CAPA, and change controls.

• Coordinate and oversee process, cleaning, equipment, and analytical method validation/qualification activities.

• Establish and monitor the company’s internal audit and self-inspection program.

• Ensure proper qualification of suppliers and vendors and participate in supplier audits where required.

• Ensure proper handling, investigation, and documentation of product complaints, recalls, and quality defects.

• Monitor environmental monitoring, sanitation, hygiene, and contamination-control requirements where applicable.

• Ensure that all quality-related records are complete, accurate, traceable, and maintained in accordance with data-integrity requirements.

• Provide GMP training to employees and ensure personnel are adequately trained for their assigned responsibilities.

• Work closely with Production, QC, Engineering, Warehouse, and Regulatory Affairs to resolve quality issues.

• Prepare quality reports and monitor quality KPIs, trends, deviations, CAPA effectiveness, and recurring problems.

• Act as a key contact during EFDA inspections, GMP audits, and regulatory assessments, and coordinate responses to inspection findings.

• Ensure implementation and follow-up of corrective and preventive actions arising from regulatory inspections and internal audits.

• Participate in new product introduction, technology transfer, process development, and scale-up from a quality perspective.

• Ensure that only products meeting approved specifications and quality requirements are released for distribution.

• Promote a strong quality culture throughout the organization and ensure quality decisions are made independently from production pressures.

Skills & Competencies

• Strong knowledge of WHO/EFDA GMP requirements and pharmaceutical quality systems.

How To Apply

Submit your application and CV along with supporting documents via email: Semirahaile8485@gmail.com