Quality Assurance Associate
SGS
full-time
Posted on:
Location Type: Remote
Location: Philippines
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About the role
- Review and approve Change Control Request and ensure their timely closure by coordinating with owners.
- Act as site representative for Trainings and Document Control systems and manage related activities.
- Maintain client test methods, specification databases, and coordinate Quality Agreement approvals internally, externally, and with Legal.
- Coordinate and support internal, client, and regulatory audits, and prepare responses to audit findings.
- Act as backup for QA functions, including release of Certificates of Analysis, vendor evaluations, and other QA management responsibilities.
- Follows Training SOP for training and training records.
- Review and approve CCRs and coordinate for their timely closure by periodic follow up with associated CR owners.
- Responsible for keeping track of upcoming periodic reviews of documents and ensure their timely completion.
- Set up all the documents in DMS and coordinate for their approvals.
- Be site representative for Trainings and Document control systems and manage all the activities for these programs.
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.
Benefits
- Health insurance
- Paid time off
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Quality AssuranceChange Control RequestGMPProtocol writingReport writingDocument Management SystemVendor evaluationsCertificates of AnalysisSpecification databasesClient test methods
Soft Skills
Communication skillsOrganizational skillsCoordination skillsAttention to detailAbility to learn quickly