QA Officer
Core
Perform Quality Assurance to support certification and release of medicinal products, maintaining the Pharmaceutical Quality System.
Role type
Quality Assurance Officer (Pharmaceutical)
Builds
Medicinal products for biopharma companies and patients
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP knowledge, EU legislation and guidelines experience, FDA GMP requirements knowledge, audit execution, project coordination, CAPA management, change control, document control, batch record review, temperature excursion assessment, SOP authoring, training delivery
Preferred skills
Analytical thinking, problem solving, decision making, self-motivation, interpersonal skills
Technologies
Inventory systems, standard computer applications
Responsibilities
Support QP in legal and operational duties, execute internal and external audits, manage deviations and complaints, coordinate investigations into quality issues, approve change controls and CAPAs, author standard operating procedures, provide QA and GMP training, assess temperature excursions, pre-certify batch records, post QP certification batch release
Seniority
Mid-level, hands-on IC
