Quality Assurance Associate
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Job Description
Pharma Quality Assurance Associate managing GMP quality systems, audits, documents, and vendor evaluations. Supporting SGS, a global inspection, verification, testing, and certification company.
Responsibilities:
- Review and approve Change Control Requests and coordinate their timely closure with owners
- Act as site representative for training and document control systems
- Track periodic document reviews and ensure timely completion
- Set up documents in the Document Management System and coordinate approvals
- Track employee training assignments and completion; evaluate retraining requirements
- Maintain and update client test methods and specification databases
- Coordinate internal, external, and Legal approvals of Quality Agreements and follow up with clients
- Coordinate customer and regulatory audits and prepare responses to audit findings
- Provide backup QA support, including releasing Certificates of Analysis and performing vendor evaluations
- Support QA management functions and corrective-action follow-up as designated
- Review method/specification assessment forms
- Participate in internal audits when required
- Work on special projects assigned by management
- Complete assigned tasks on time and notify the GBS Team Coordinator or Lab Manager of foreseeable delays
- Support operational improvement activities focused on quality and efficiency
- Perform other related duties supporting departmental goals and professional development
Requirements:
- Bachelor’s degree related to a scientific area is required
- Minimum 3 years of working experience in Quality Assurance in the Pharma industry is required
- Demonstrated understanding of relevant GMP (Good Manufacturing Practice) regulations is required
- Knowledge of compendiums such as USP is preferred
- Proficiency in Microsoft Office applications, including Outlook, Word, and Excel
- Ability to learn new technologies quickly
- Excellent written and strong verbal communication skills in English (C1)
- Strong written and verbal communication skills in English (B2+)
- Protocol and report writing compliant with regulatory standards
- Proven ability to manage and coordinate multiple tasks in a fast-paced, professional environment
- Proven time management skills and ability to prioritize tasks effectively to meet supervisor deadlines
- Detail-oriented with ability to identify minor discrepancies
- Must comply with SGS Code of Integrity and Professional Conduct and SGS QHSE requirements
Benefits:
- Remote work option
- Hybrid setup after 3 months onsite
- Professional training, education, and development opportunities
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