Anna Candido Email & Phone Number

Udine, It

Udine

Main Activities: Maintain updated with cGMP and in good working order the quality system of the production site and the related documentation like SOPs, VMP and SMF; Review batch record documentation and support the QP in batch disposition; Audit trail verification for production and QC equipment; Collaborate with QC and Manufacturing department in the deviations investigation and in the identification and implementation of CAPAs; Oversee change control processes to evaluate and approve changes to procedures, equipment, or facilities, ensuring minimal impact on product quality and regulatory compliance; Coordinate risk assessments and gap analysis necessary to spot eventual criticalities and implement data driven decisions; Conduct product quality reviews to assess the state of the pharmaceutical production process and identify opportunities for improvement; Monitor suppliers quality performance, ensure compliance with quality standards and specifications, and handle complaints; Support Production and QC in validation activities.

Piombino Dese, Veneto, Italy

Main Activities: Single point of contact for Pharma Companies concerning pre-sales and post-sales technical and quality topics related to glass primary packaging; Management of Customers’ requests in collaboration with internal functions (in particular QA, RA, R&D, Operations and Sales Department); Support Customers’ in defining their requirements for primary packaging and in selecting the appropriate product; Communication management in case of Customer’ s complaints and support the internal functions in the root cause investigation; Evaluation and communication of changes and deviations to the assigned Customers.Experience with the following Regulations/Directives/Guidelines/Standards: EudraLex Vol. 4, ISO 13485, ISO 15378, ISO 9001, ISO 11040, ISO 10993, ISO 7864, ISO 9626, ISO 8362, ICHQ3D, REACH, EMA/410/01, Directive 94/62/CE.

Piombino Dese, Veneto, Italia

Main activities: Managing of Customer and Quality Specifications, Customer driven projects on quality and technical topics (P-PAP dossier, process capability studies, measure system analysis), Statistical data analysis, Root cause investigation for Customer complaints using A3 problem solving method.

Piombino Dese, Veneto, Italia

Main Activities: Customer support on regulatory aspects of pharmaceutical primary packaging, Declarations and reports on products compliance to applicable standards, norms and regulations (ICHQ3D, ISO 11040, ISO 10993, ISO 7864, ISO 9626, REACH, EMA/410/01), Managing of declarations on frequent asked question about quality topics.

Trieste

Laboratory of Pharmaceutical Technology - Department of Chemistry and Pharmaceutical SciencesThesis Title: “Mechanochemical activation of Praziquantel using nanoporous silica as excipient”Main equipment used and activities performed: Vibrational grinder, Differential scanning calorimetry, Hot-stage microscopy, UV/Vis spectroscopy, FT-IR spectroscopy, Dissolution test.

Trieste

Pharmacology Laboratory - Department of Life SciencesInternship during an in vivo study on a treatment for Chronic Lymphocytic Leukaemia based on Antagomir17 loaded on nanoparticles conjugated to antiCD20 antibodies.Main activities: handling and monitoring SCID mice, observing treatment procedure, extraction and preparation of biological samples.

Trieste, Italia

Main activities: Customer assistance, Dispensation of prescriptions, Preparation of extemporaneous medications, Stock management.

Postgraduate Specialisation And Advanced Professional Training Course (Eqf Level: 8), Gmp Compliance Quality Expert For Pharmaceutical Operations

Main Topics: Basics of process engineering; cGMP compliance applied to facilities and processes; GMP inspections; Critical utilities.

Pharmacist License

Master’S Degree, Pharmaceutical Chemistry And Technology