Quality Assurance Specialist
Aodh Lifesciences is seeking a Quality Assurance Specialist to manage the quality lifecycle of scientific and regulatory documentation. The role requires enforcing GxP compliance and ALCOA+ principles across all data packages and records. Key tasks include managing the Document Management System, conducting internal audits, and overseeing CAPA and change control processes. The position serves as a quality gate for regulatory submissions, ensuring all documentation is audit-ready.
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Experience
3-5 years
Function
Quality Assurance
Work mode
Onsite, India
Company
Tier 2
What you will work on
Aodh Lifesciences is seeking a Quality Assurance Specialist to manage the quality lifecycle of scientific and regulatory documentation. The role requires enforcing GxP compliance and ALCOA+ principles across all data packages and records. Key tasks include managing the Document Management System, conducting internal audits, and overseeing CAPA and change control processes. The position serves as a quality gate for regulatory submissions, ensuring all documentation is audit-ready.
TAL's take
Specific role at a research-focused healthtech company with clear responsibilities, though the company brand is not yet widely established.
Extremely clear, well-defined documentation and compliance-focused scope for a Quality Assurance Specialist.
Must haves
- 3-5 years experience in pharmaceutical or life sciences quality assurance
- Master's degree in Pharmacy related field
- Expertise in GxP and ALCOA+ principles
- Experience managing Document Management Systems
- Knowledge of CAPA and Change Control processes
- Familiarity with regulatory submission standards like CTD
Tools and skills
About the company
Unfamiliar company in the healthtech sector, defaulting to mid-tier as a research-driven life sciences firm.