Quality Assurance Associate
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Job Description
Pharma quality assurance associate supporting audits, document control, and GMP compliance at SGS. Managing quality agreements, training records, vendor evaluations, and Certificates of Analysis.
Responsibilities:
- Review and approve Change Control Requests and ensure timely closure by coordinating with owners
- Act as site representative for Training and Document Control systems and manage related activities
- Track periodic document reviews and ensure timely completion
- Set up documents in the Document Management System and coordinate approvals
- Track employee training assignments and ensure timely completion
- Evaluate retraining requirements for SOPs
- Maintain and update client test methods and specification databases
- Coordinate Quality Agreement approvals internally, externally, and with the SGS legal team
- Follow up with clients for timely Quality Agreement approvals
- Coordinate customer and regulatory audits
- Prepare client responses to audit findings
- Provide backup QA support, including releasing Certificates of Analysis
- Perform vendor evaluations and follow up with vendors
- Review method/specifications assessment forms when provided
- Participate in internal audits and follow up on corrective actions
- Work on special projects assigned by Management
- Notify the GBS Team Coordinator or section Lab Manager of foreseeable delays
- Support operational improvement activities focused on quality and efficiency
- Perform other related duties supporting departmental goals or personal and professional development
- Report operationally to the Affiliate lab manager or supervisor and administratively to the GBS Supervisor
Requirements:
- Bachelor’s degree related to scientific area is required
- Minimum 3 years working experience in Quality Assurance in Pharma industry is required
- Demonstrated understanding of relevant GMP (Good Manufacturing Practice) regulations is required
- Knowledge in compendiums such as USP is preferred
- Proficiency in Microsoft Office applications, including Outlook, Word, and Excel
- Ability to learn quickly new technologies
- Excellent written and strong verbal communication skills in English (C1)
- Protocol and report writing compliant with regulatory standards
- Strong written and verbal communication skills in English (B2+)
- Proven ability to manage and coordinate multiple tasks in a fast-paced, professional environment
- Proven time management skills and proficiency in effectively prioritizing tasks to meet deadlines set by Supervisors
- Detail-oriented with the ability to identify minor discrepancies
- Must comply with SGS Code of Integrity and Professional Conduct and SGS QHSE
Benefits:
- Employees can work remotely
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