Quality Unit Manager and Qualified Person

2 settimane fa


Rome, Italia Antal International Network A tempo pieno
Job DescriptionAntal International is a Multinational Headhunting Company with more than 140 offices in 40 countries. Life Science is a Team specialized in profiles with a Scientific and Engineering background in Manufacturing, Production, Engineering, SCM, Research and Development, Medical, Quality and Technical-Commercial in Pharmaceutical, Pharmaceutical Chemistry, Biotech, Chemical, Cosmetic, Medical, Diagnostic, Plastic Rubber, Food sectors.The CompanyMultinational Pharmaceutical is searching a:The RoleQuality Unit Manager and Qualified PersonThe candidate will be responsible for:Manage the batch disposition process to ensure timely release of productEnsure the batch disposition process maintains compliance with site practices & regulatory requirementsSupport major investigations, ensuring all product deviations are closed prior to batch releaseParticipate in cross functional teams as Quality/Qualified Person representativeProvide additional QP support to quality related issues, as the need arisesParticipate on internal committees/teams, as requiredProvide advice and direction to other departments on quality issuesReporting to Quality Unit site Director ensure independence of the QP on decisions on quality related mattersBuild partnerships across the business to create a culture that demonstrates excellence in quality, compliance and continuous improvementsProvide audit support as required for internal auditing program and supplier auditsPersonal AttributesPost Graduate Qualification required (MSc or equivalent)Ideally 8+ years of cGMP experience with relevant work experience acting as Qualified Person, named on the Manufacturer's/Importer's Authorization (MIA) ; consideration will be given to other relevant experience and educationExperience in managing Health Authority audits, CAPA plan and its related documentation Pharmaceutical manufacturing experience in Sterile and API manufacturing highly desirableProven leadership skills comparable to 2+ years of management responsibilityProblem solving, risk assessment and impact analysis abilities Training/mentoring experienceItalian and English fluent languagesLocation:

MILANO OVESTPlease send your CV and motivation letter to the role to: lcarbone@antal.comRef: Quality Unit Manager and Qualified PersonIf not in possession of all the requirements indicate as reference: SELF-CANDIDATIONApplications deemed online will be contacted within 30 days of receipt of the application.Thanks in advance to all those who want to send us their CV, in case of failure to call, we will consider the professional profile for any future needs.Apply NowCheck Your Resume for MatchUpload your resume and our tool will compare it to the requirements for this job like recruiters do.
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