PDS QA Project Specialist
Core
Supports the Qualified Person (QP) in evaluating and certifying manufactured batches and the manufacturing environment through review of quality documentation and compliance with GMP/FDA regulations.
Role type
Quality Assurance Project Specialist (Pharmaceutical)
Builds
Certified pharmaceutical batches and compliant manufacturing environments
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
client delivery
Required skills
GMP regulations knowledge, deviation investigation, CAPA management, root cause analysis, aseptic manufacturing process understanding, batch record review, SOP maintenance, risk assessment, FMEA review, PSF preparation
Preferred skills
Customer complaint management, audit preparation support, change control review, protocol and report review
Technologies
TrackWise
Responsibilities
Review Certificates of Analysis and supporting quality documentation; perform preliminary impact assessments of deviation events; manage customer complaints; approve CAPAs and evaluate effectiveness verification; prepare Product Summary Files (PSFs) for clinical batches; maintain and update Standard Operating Procedures (SOPs); review Master Batch Records, Change Controls, and protocols associated with PDS projects.
Seniority
Mid-level, hands-on IC