We are currently looking for a Senior Quality Assurance Officer (Quality Operations) to join our team.
In this role, you will play a pivotal role in upholding our commitment to quality and compliance. You will collaborate with a cross-functional team to ensure that Batch Documentation Package required for Batch Certification activities adhere to GMP standards, company procedures, and regulatory guidelines.
Key Responsibilities:
- Support the maintenance and continuous improvement of the Quality Management System (QMS) in compliance with GMP requirements and regulatory standards.
- Assist the Qualified Person (QP) with batch certification activities, including the review of batch documentation to ensure compliance with approved product dossiers and marketing authorisations.
- Collaborate with Contract Manufacturing Organisations (CMOs) and internal stakeholders to resolve documentation issues and support the timely closure of deviations, CAPAs, and change controls.
- Manage quality-related activities including Product Quality Reviews (PQRs), market complaints, audit documentation, change evaluations, and QP declarations in accordance with company procedures.
- Participate in self-inspections and external audits, providing quality assurance support to maintain compliance and drive continuous improvement.
Job Requirements:
- Degree in a scientific field (Chemistry, Pharmacy, or related discipline)
- Minimum of 4 years of experience in pharmaceutical quality assurance or a related field
- Demonstrated expertise in GMP principles and regulatory requirements
- Strong QA skills and meticulous attention to detail
- Excellent communication and interpersonal skills, with fluency in English (both written and verbal)
- Proactive, results-oriented, and capable of working independently and as part of a team
What we offer:
- Competitive remuneration package
- Comprehensive health insurance
- Continuous professional growth opportunities in a state-of-the-art Testing and Batch Certification Facility.