-Planning and supporting PQR/APQR activities -Support site qualification and validation activities (planning, advising, review) -Implementation of Quality Systems (incl. documentation management) -Supplier management activities (agreements, oversight, audit) -Preparation/support & coordination of CAPA/follow-up -Audit and inspection preparation and support -Change control review/approval -Ensure local DI and eCompliance oversight (training, inspections, plan, risk ID etc) -Ensure process quality assurance acc. to regulations -QP declaration review & approval -KPI trending -Ensure applications, certificate maintenance etc. to local HA -SPOC for communication with HA, GCA / One voice / consolidated approach / synergies for all sites within same HA jurisdiction / country -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment
and diverse teams representative of the patients and communities we serve.
Minimum requirements
QC/ QA in pharmaceutical ind./ biotech with environmental monitoring &
cleanliness zones English Knowledge of GMP Knowledge of IT Applications &
tools Knowledge of Core work processes Quality Standards Quality Assurance
Division
Operations
Business Unit
QUALITY
Country
Egypt
Work Location
Cairo
Company/Legal Entity
NOV PHARMA EGY
Functional Area
Quality
Job Type
Full Time
Employment Type
Regular
Shift Work
Yes
Early Talent
Yes
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