Quality Assurance Associate

This is a fully remote position, open to applicants in Poland.

📋 Description

• Evaluate and authorize Change Control Requests, ensuring their prompt resolution with responsible parties.

• Serve as the site representative for training and document management systems.

• Monitor periodic document assessments and guarantee timely execution.

• Organize documents within the Document Management System and facilitate the approval process.

• Oversee employee training assignments and their completion; assess needs for retraining.

• Maintain and refresh client testing methods and specification databases.

• Manage internal, external, and legal approvals of Quality Agreements and follow up with clients.

• Coordinate customer and regulatory audits, preparing responses to any audit findings.

• Provide backup Quality Assurance support, including the issuance of Certificates of Analysis and conducting vendor evaluations.

• Assist in QA management tasks and follow up on corrective actions as assigned.

• Review method and specification assessment documents.

• Participate in internal audits as necessary.

• Engage in special projects as assigned by management.

• Complete tasks within deadlines and inform the GBS Team Coordinator or Lab Manager of any anticipated delays.

• Contribute to operational improvement initiatives focused on quality and efficiency.

• Perform additional duties that support departmental objectives and professional growth.

⛳️ Requirements

• A Bachelor’s degree in a scientific field is mandatory.

• At least 3 years of experience in Quality Assurance within the pharmaceutical sector is essential.

• A solid understanding of applicable GMP (Good Manufacturing Practice) regulations is required.

• Familiarity with compendiums such as USP is preferred.

• Proficiency in Microsoft Office Suite, including Outlook, Word, and Excel.

• Ability to quickly grasp new technologies.

• Excellent written and strong verbal communication skills in English (C1).

• Strong written and verbal communication skills in English (B2+).

• Experience in protocol and report writing in accordance with regulatory standards.

• Proven capability to manage and coordinate several tasks in a dynamic, professional setting.

• Demonstrated time management skills and the ability to prioritize tasks effectively to meet supervisory deadlines.

• Detail-oriented with a keen ability to spot minor discrepancies.

• Must adhere to the SGS Code of Integrity and Professional Conduct, as well as SGS QHSE requirements.

🏝️ Benefits

• Option for remote work.

• Hybrid work setup after 3 months onsite.

• Opportunities for professional training, education, and development.