Qualified Person for Batch Release

Job Overview

We are looking for an experienced Qualified Person responsible for approving batch release of medicinal products. This role involves verifying that all manufactured or packaged batches comply with European GMP standards and marketing authorizations before release.

Qualifications

• Bachelor of Science degree in Pharmacy or a related scientific discipline.
• Additional certifications in GMP, Quality Control or Quality Assurance.
• A minimum of five years' hands-on experience in companies authorized for manufacturing medicinal products, focusing on quality management system development and implementation.
• Fluent English communication skills are essential.

Key Responsibilities

• Authorizing the release of batches produced onsite or via third-party manufacturers, including new product introductions.
• Ensuring all batches conform to the current EU GMP Directives and specific marketing authorizations.
• Confirming compliance with Marketing Authorization and Manufacturing Authorization requirements for each batch.
• Verifying validation of principal manufacturing and testing processes.
• Reviewing batch records and ensuring completion of all quality control checks including manufacturing and packaging conditions.
• Overseeing reporting and management of any changes or deviations in manufacturing, packaging, or QC processes prior to product release.
• Managing additional sampling, inspections, or tests as necessary to address changes or deviations.
• Ensuring all manufacturing and packaging documentation is properly completed and authorized.
• Coordinating regular audits, self-inspections, and random checks by qualified personnel, and ensuring ongoing technical and professional development for staff involved in batch release.

Additional Benefits

• Becoming an integral part of the global SA Infinity team.
• Opportunities to gain international work experience.
• Professional and personal development prospects.
• Enhancing teamwork and collaboration skills.