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Company Description A.B. Enterprises is a growing 3PL logistics service provider organization focused on delivering high-quality products and services to a diverse company base. The company values operational excellence, continuous improvement, and adherence to industry standards and regulations. We are seeking an experienced and highly motivated Quality Assurance (QA) Manager to lead and manage the Quality Management System (QMS) for our pharmaceutical 3PL warehousing and distribution operations. The candidate will be responsible for ensuring compliance with GDP, regulatory requirements, client quality standards, and internal quality procedures.
Key Responsibilities
Maintain and continuously improve the Quality Management System (QMS).
Manage SOPs, Forms, and Quality Records.
Control document issuance, revision, archival, and retrieval processes.
Ensure implementation of quality policies and procedures across warehouse operations.
Compliance & Audits
Ensure compliance with WHO GDP, Good Storage Practices, and customer quality requirements.
Coordinate external audits, internal audits, and regulatory inspections.
Track audit observations and ensure timely closure of CAPAs.
Conduct periodic self-inspections and compliance reviews.
Validation & Qualification
Review and approve warehouse qualification documents.
Manage temperature mapping, HVAC qualification, cold room qualification, and equipment validation activities.
Ensure calibration and preventive maintenance programs are effectively implemented.
Deviations, CAPA & Change Control
Investigate deviations, non-conformances, and customer complaints.
Conduct root cause analysis and implement corrective and preventive actions (CAPA).
Manage change control processes and assess quality impact.
Training & Quality Culture
Conduct GDP, SOP, and quality compliance training for employees.
Maintain training records and competency assessments.
Promote a culture of quality and continuous improvement.
Inventory & Warehouse Quality Oversight
Monitor storage conditions, temperature excursions, and warehouse compliance.
Ensure proper handling of pharmaceutical products, returns, expired goods, and destruction activities.
Support inventory reconciliation and quality-related investigations.
Qualifications
Bachelor's or Master's Degree in Pharmacy, Life Sciences, Chemistry, or related field.
Minimum 2–3 years of experience in pharmaceutical quality assurance.
Experience in pharmaceutical warehousing, C&F operations, 3PL logistics, or distribution is preferred.
Strong knowledge of GDP, GSP, CAPA, Change Control, Deviation Management, and Risk Assessment.
Experience handling audits and regulatory inspections.
Excellent documentation, communication, and leadership skills.
Preferred Skills
Knowledge of warehouse quality management systems.
Experience in temperature mapping and qualification activities.
Strong analytical and problem-solving abilities.
Team management and stakeholder coordination skills.
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