QA Compliance Officer - Genepharm

We are seeking a detail-oriented and highly motivated QA Compliance Officer to join our Quality Assurance team.

The successful candidate will support the effective implementation and maintenance of the company’s Pharmaceutical Quality System (PQS), with a particular focus on SOP management, training oversight, Deviations, Change Controls, Complaint handling, and audit/inspection readiness.

Main Responsibilities

• Prepare, review, revise, and maintain Standard Operating Procedures (SOPs) and other Quality Management System documentation.
• Coordinate and oversee the company’s GMP training system, including training assignment, completion monitoring, maintenance of training records, and follow-up of training activities.
• Manage and support Deviations, ensuring appropriate investigation, documentation, root cause analysis, impact assessment, and timely closure.
• Manage and coordinate Change Controls, ensuring appropriate assessment, documentation, implementation, follow-up, and timely closure.
• Manage and coordinate product quality complaints, including investigation, assessment, documentation, follow-up, and timely closure.
• Collaborate with relevant departments to ensure timely and effective investigation and resolution of quality-related issues.
• Support the preparation and coordination of customer audits and Regulatory Authority inspections.
• Assist in inspection readiness activities, including documentation preparation, coordination with involved departments, and follow-up of audit/inspection requests.
• Support the preparation and follow-up of responses and related actions arising from audits and inspections.
• Monitor compliance with established Quality System procedures and applicable cGMP requirements.
• Support the continuous improvement and effectiveness of the Pharmaceutical Quality System.
• Maintain accurate, complete, and traceable Quality System documentation and records.

Requirements

• University degree in Pharmacy, Chemistry, Biology, Chemical Engineering, or another relevant scientific field.
• At least 2 years of relevant experience in Quality Assurance within the pharmaceutical industry is highly desirable.
• Hands-on experience in SOP management, GMP training activities, Deviations, Change Controls, and/or Complaint handling.
• Good knowledge and understanding of cGMP requirements and Pharmaceutical Quality Systems.
• Experience in supporting customer audits and/or Regulatory Authority inspections is highly desirable.
• Knowledge of investigation, root cause analysis, and Quality Risk Management principles is desirable.
• Very good command of written and spoken English.
• Excellent command of MS Office applications (Word, Excel, Outlook).
• Strong technical writing and documentation skills.
• Strong organizational skills and attention to detail.
• Good communication and interpersonal skills, with the ability to collaborate effectively across different departments.
• Ability to manage multiple priorities and work effectively within established timelines.

The Company Offers

• Competitive salary and benefits package.
• Opportunities for professional growth and development.
• Exposure to pharmaceutical Quality Systems, audits, and regulatory inspections.
• A supportive and collaborative work environment