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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Assurance within the pharmaceutical industry, with a strong focus on compliance with GMP, GDP, and GVP standards. Proficient in managing deviations, CAPAs, and risk management activities while fostering a culture of continuous improvement.
Highest-signal resume keywords
Doctor Of Pharmacy (PharmD)Quality Assurance ExperienceGMP (Good Manufacturing Practices)Quality Management SystemsFluent English
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Deviations ManagementCAPAs ManagementChange ControlsRoot Cause Analysis (RCA)Risk ManagementQuality Impact EvaluationsProduct Quality ReviewsQuality KPIs Monitoring
Soft Skills
CollaborationCommunication
Tools & Technologies
TrackWiseEDMSSAP
Certifications & Qualifications
Registration As A Responsible Pharmacist (PRI)
Industry Keywords
Pharmaceutical RegulationsQuality StandardsPharmacovigilanceInternal AuditsSupplier Audits
About the role
Key responsibilities & impact- Manage and maintain quality documentation, including SOPs, procedures, and quality records
- Coordinate document lifecycle activities, including creation, review, approval, archiving, and periodic reviews
- Support and deliver GxP and quality-related training programs
- Participate in internal audits, supplier audits, and health authority inspections
- Manage deviations, CAPAs, change controls, and continuous improvement initiatives
- Ensure compliance with applicable pharmaceutical regulations and quality standards
- Manage product quality complaints and associated investigations
- Support quality defect reporting and interactions with health authorities
- Conduct risk assessments and quality impact evaluations
- Participate in product recall and shortage management activities
- Review Product Quality Reviews and monitor quality trends
- Review and approve batch release documentation and distribution-related quality activities
- Monitor quality KPIs and performance indicators
- Contribute to Management Reviews and Annual Quality Reviews
- Support product launches, technology transfers, and portfolio optimization projects
- Drive quality culture and continuous improvement across the organization
- Collaborate with Manufacturing, Supply Chain, Regulatory Affairs, Pharmacovigilance, and Quality stakeholders
Requirements
What you’ll need- Doctor of Pharmacy (PharmD) mandatory
- Strong experience in Quality Assurance within the pharmaceutical industry
- Experience in pharmaceutical manufacturing or production environments is highly desirable
- Registration as a Responsible Pharmacist (PRI) is considered an asset
- Strong knowledge of GMP (Good Manufacturing Practices), GDP (Good Distribution Practices), GVP, and Pharmacovigilance requirements
- Proven experience managing deviations, CAPAs, change controls, root cause analysis (RCA), and risk management activities
- Experience with Quality Management Systems and tools such as TrackWise, EDMS, SAP, and other electronic Quality Systems
- Fluent English, both written and spoken
Benefits
Comp & perks- Opportunity to work at a young and ambitious healthcare company with 900 employees
- Diverse and stimulating projects across full-service, functional service provider, and consulting models
- Collaboration with leading experts
- International, fast-growing environment
- Employee experience-focused culture
- Opportunities to contribute to scientific, operational, and human knowledge
- Environment encouraging natural talents, boldness, initiative, and professional growth
