Senior Quality Assurance Officer (Quality Management Systems)

We are looking for a detail-oriented Senior Quality Assurance Officer (Quality Management Systems) to support our quality management system and ensure continued compliance with applicable regulatory requirements. The role directly reports to the Quality Management Systems Manager.

Key Responsibilities:

• Prepare, update and maintain SOPs/SOFs in line with company policies and EU cGMP.
• Assist in the preparation for incoming regulatory and client audits and participate in self-inspection programme
• Maintain QA documentation, quality logs, and document registers to ensure regulatory compliance and quality assurance
• Assist in the investigation of deviations
• Collaborate cross-functionally with internal departments to ensure that regulatory requirements are integrated into company processes.
• Assist in the implementation and maintenance of the company’s training programme and ensure employee training.
• Management of the Supplier Qualification Process.
• Review Corrective and Preventive Actions (CAPAs) to ensure proper implementation and adherence, overseeing the CAPA Program for continuous improvement.
• Support in the external audit programme.
• Assist in the registering, follow up, performing risk assessments and closure of change controls as necessary.
• Assist in the review of asset’s calibration and/or qualification documentation

Requirements:

• Bachelor’s degree or higher in Pharmacy, Life Sciences, or a related discipline.
• Minimum of 4 years’ experience in Quality Management within the pharmaceutical industry.
• Sound knowledge of EU and local regulatory requirements.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.
• Strong organisational skills, with a high level of attention to detail.
• Must be in possession of a valid work permit.

What we offer:

• Competitive remuneration package
• Comprehensive health insurance
• Continuous professional growth opportunities in a state-of-the-art Testing and Batch Certification Facility.