DQA
Core
Managing document control, quality system compliance, and batch release activities for pharmaceutical and biotech products.
Role type
Quality Assurance Specialist (Document Control & Compliance)
Builds
Quality management systems, validated documents, and compliant batch releases for drug discovery and development.
Domain
Pharmaceutical / Biotechnology / Regulatory Compliance
Deliverable
client delivery
Required skills
Document control, SOP review and approval, deviation management, CAPA handling, audit support, batch release, vendor qualification, analytical report review, equipment qualification review, audit trail verification
Preferred skills
MSc degree, immediate availability
Technologies
QMS systems, Archival Systems, Laboratory Information Management Systems (implied by lab notebook review)
Responsibilities
Revision and issuance of quality documents, handling master documents (SOPs, specifications, validation protocols), preparing master document lists, reviewing SOPs across departments, handling dispatch and archival activities, managing vendor qualification, addressing customer queries, conducting IPQA rounds, supporting internal and customer audits, reviewing ATR/COA, executing lab notebook and R&D data reviews, approving raw and packing materials, releasing finished products.
Seniority
Mid-level, hands-on IC