Clinical Specialist, Quality Assurance
Clinical Specialist, Quality Assurance
intrinseque health- Posted a day ago
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Job Description
The role includes supporting and maintaining quality standards across clinical and operational processes. The role includes managing QMS documentation, SOPs, CAPA, deviations, non-conformances, audits, quality investigations, and compliance activities, while ensuring processes align with applicable regulatory and quality requirements.
Qualifications
- Bachelor's/Master's degree in Pharmacy, Biotechnology, Life Sciences, Microbiology, or a related field
- Minimum 2–3 years of relevant experience in Clinical QA / Quality Assurance is mandatory
- Bachelor's/Master's degree in Pharmacy, Biotechnology, Life Sciences, or a related field
- Strong knowledge of Quality Management Systems (QMS)
- Experience in SOP preparation, review, implementation, and maintenance
- Hands-on experience in CAPA management
- Experience in deviation and non-conformance management
- Experience in quality investigations and root cause analysis
- Experience in internal and external audits
- Knowledge of GxP and applicable regulatory requirements
- Experience in quality documentation and compliance monitoring
- Ability to support quality improvement and compliance initiatives
- Strong written and verbal communication skills
- Ability to work effectively with cross-functional teams
More Info
Key Skills
CAPA management
Quality investigations and root cause analysis
Quality documentation and compliance monitoring
Knowledge of GxP and applicable regulatory requirements
Internal and external audits
Deviation and non-conformance management
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