Quality and Process ValidationDettagli sul clienteBiomedical companyDescrizioneIt is the responsibility of the Quality and Process Validation to manage all microbiological, sterilization and biocompatibility services under the general supervision of the function responsible. All the analysis are entrusted to external qualify Suppliers: the frequent and positive collaborations with external Laboratories is part of the daily job activities.Main Job tasks/ responsibilities:
guarantee the compliance and monitoring of manufacturing areas to the applicable standards classification: routine environmental controls management/review, hygienic rules definition for personnel and environment, cleaning solutions and cleaning program;
manage the routine sterilization process;
review all microbiological analysis on products/semiassemblies, components, supplies, etc. (e.g. sterility testing, bioburden, bacterial endotoxins) defining and managing when applicable testing to be performed, and validating new methods in collaboration with the external Laboratories, when required;
define the biological evaluation plan and report, as well as review biocompatibility test reports and chemical characterization/toxicological assessments;
manage and document the department not conformances according to Quality System requirements, documenting appropriately the root cause analysis (according to adequate quality tools), and define and implement corrective actions and verifications;
evaluate the impact of process deviations and of not conforming product or suspected to be not conforming;
analyse processes data for trends and communicating to peers and management to identify issues and improvement opportunities;
participate to ensures that all processes under Microbiology and Biocompatibility function duties are compliant to QMS requirements and GMP;
participate to validation of all the sterilization methods processes according to the applicable standards;
provide support in all Microbiology/Sterilization/Biocompatibility matters on new products development and on the business continuity (e.g: supplier/process changes);
participate to development, reviews and approval of quality system procedures, investigation (e.g. corrective and preventive actions) and audit responses;
develop and maintain effective relationships with internal personnel and external stakeholders to facilitate and drive the resolution of regulatory compliance and product quality issues.
As part of the Quality Team:
participate to the CAPA system and subsystem by trends analysis, driving root cause analysis and risk management activities, as necessary;
assist on quality audits;
leads effective meetings, conducts presentations, keeps quality records, meeting minutes and action items including follow up.
Excellent written and verbal communication skills.
Ability in issuing validation protocol/reports, data trend, technical rational, assessments etc.
Frequent use and application of technical standards, engineering principles, theories, concepts, and techniques as well as statistical elements
Application of pertinent regulations (e.g., ISO 13485 and 21 CRF Part 820) and knowledge of the standards related to microbiology, sterilization and environmental controls.
English advanced level is a must.
Proficient in MS Office including Word, Power Point, and Excel.
Strong interpersonal skills.
Attention to details, sense of responsibility.
Chemical/pharmaceutical background is a plus.
ExperienceAt least four years of experience in a biomedical company or other highly regulated environment.offerta di lavoroOttima opportunità di carriera.