Quality Assurance Associate

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

📋 Description

• Review and authorize Change Control Requests while ensuring their prompt resolution by liaising with responsible parties.

• Serve as the site representative for Training and Document Control systems, overseeing associated activities.

• Monitor periodic document reviews and guarantee their timely completion.

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

• Track employee training assignments to ensure they are completed on time.

• Assess the need for retraining regarding Standard Operating Procedures (SOPs).

• Maintain and update databases for client test methods and specifications.

• Facilitate the approval of Quality Agreements both internally and externally, including coordination with the SGS legal team.

• Follow up with clients to ensure prompt approvals of Quality Agreements.

• Organize customer and regulatory audits.

• Prepare responses to clients concerning audit findings.

• Provide backup QA support, which includes issuing Certificates of Analysis.

• Conduct vendor evaluations and maintain communication with vendors.

• Review method/specifications assessment forms as they are submitted.

• Engage in internal audits and follow up on necessary corrective actions.

• Participate in special projects as assigned by Management.

• Alert the GBS Team Coordinator or section Lab Manager of any anticipated delays.

• Support initiatives aimed at improving operational quality and efficiency.

• Execute other related tasks that contribute to departmental objectives or personal and professional growth.

• Report operationally to the Affiliate lab manager or supervisor and administratively to the GBS Supervisor.

⛳️ Requirements

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

• A minimum of 3 years of experience in Quality Assurance within the pharmaceutical industry 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 applications, including Outlook, Word, and Excel, is expected.

• Capability to quickly grasp new technologies.

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

• Ability to write protocols and reports in accordance with regulatory standards.

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

• Proven ability to juggle and coordinate multiple tasks in a fast-paced, professional setting.

• Demonstrated time management skills with a proficiency for prioritizing tasks to meet deadlines established by Supervisors.

• Detail-oriented with an aptitude for identifying minor discrepancies.

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

🏝️ Benefits

• Employees have the option to work remotely.