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Chiesi Group
Chiesi Group
5.001 – 10.000 Angajați
Asistență medicalăIndustria prelucrătoareProduse farmaceutice
Chiesi Group este o companie farmaceutică globală axată pe cercetarea, dezvoltarea și comercializarea unor medicamente inovatoare. Activitatea sa acoperă bolile respiratorii, îngrijirea specializată și bolile rare, având ca obiectiv mai amplu îmbunătățirea sănătății și bunăstării pacienților. Compania pune, de asemenea, accent pe sustenabilitate, responsabilitate corporativă și protecția mediului, ca parte a abordării sale în domeniul sănătății.
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Validation and Equipment Compliance Manager — Parma, Italy

Senior validation leader responsible for GMP qualification, validation, data integrity, and compliance at Chiesi Group’s biopharmaceutical manufacturing site in Parma. Oversees risk management, inspections, quality systems, and continuous improvement.

ITItalia
52.000 € – 65.000 € / an
La sediuNormă întreagăSeniorLiderLimbă Obligatorie: englezăConformitate

Descriere

  • Provide Quality oversight and formal approval for qualification and validation work in line with applicable regulations and guidance
  • Direct the site Validation Program across equipment, processes, utilities, facilities, computerized systems, cleaning procedures, and laboratory instruments
  • Verify that products consistently perform as intended and meet established quality requirements
  • Maintain regulatory and GMP compliance across validation and qualification activities throughout the equipment lifecycle
  • Ensure Data Integrity compliance for site computerized systems and govern Computerized System Validation across GMP areas, API manufacturing, and Finished Product manufacturing
  • Support Quality Management through departmental budgeting, workforce planning, competency development, organizational design, objectives, training, coaching, and competency alignment
  • Monitor compliance with company values, the code of conduct, ethical principles, and legal and contractual obligations
  • Manage personnel and coordinate team activities in accordance with labor, contractual, health, and safety requirements
  • Oversee maintenance activities and measures designed to reduce health and safety risks
  • Recommend investments that improve safety, compliance, and operational performance
  • Fulfill mandatory health and safety information, training, and instruction requirements
  • Work with EHS on the departmental Risk Assessment Document (DVR)
  • Implement and supervise risk controls, emergency and evacuation procedures, protective measures, and PPE requirements
  • Oversee Validation Project Plans and Validation Final Reports
  • Supervise Technology Transfer documentation
  • Lead validation and qualification activities while reviewing supporting data and corrective actions
  • Support equipment lifecycle management, including qualification, maintenance, and calibration planning
  • Conduct QA review and approval of validation documentation, including URS, DQ, FAT, SAT, IQ, OQ, PQ, and PV
  • Support investigations into qualification deviations and evaluate their regulatory and operational impact
  • Manage environmental and cleaning validation activities
  • Prepare shipping validation protocols and reports to support GDP compliance
  • Support new site projects and ongoing process verification plans
  • Review Computerized System Validation documentation and periodic review plans
  • Support process risk assessments by identifying CPPs, CQAs, and validation strategies
  • Coordinate cross-functional risk assessments for projects and regulatory submissions
  • Partner with Production on GMP requirements, production planning, process validation, and cleaning validation
  • Support complaint and quality event investigations and implement CAPA plans
  • Issue and maintain procedures
  • Participate in self-inspections, regulatory inspections, and customer audits
  • Maintain the Validation Change Control Program and Validation Management System
  • Review and approve the Validation Master Plan
  • Serve as the Validation SME for process validation, process changes, cleaning validation, hold times, and analytical instrumentation qualification
  • Deliver training on Validation, Qualification, and Change Management processes
  • Lead continuous improvement efforts that streamline validation and reduce non-value-added work
  • Provide leadership for validation-related CAPA activities
  • Participate as Validation SME in Quality Risk Management, FMEAs, and Risk Control Plans

Cerințe

  • Bachelor’s or master’s degree in a scientific or engineering field, such as Chemistry, Pharmaceutical Chemistry and Technology, or Engineering
  • At least 8–10 years of experience in pharmaceutical or biopharmaceutical manufacturing, including Engineering, Production, Process Technology, QA Validation, Technical Services, or Quality Assurance
  • Extensive experience validating and qualifying equipment and systems in cGMP-regulated environments
  • Strong understanding of EU and FDA regulations, with direct experience supporting regulatory inspections such as FDA or DEA inspections
  • Demonstrated experience managing validated and qualified systems
  • Ability to define and execute effective strategies while managing multiple projects concurrently
  • Strong technical problem-solving ability, including risk assessment and development of balanced, compliant solutions
  • High initiative, accountability, and decision-making capability, with the independence to work effectively with limited supervision
  • Excellent collaboration and interpersonal skills, with the ability to build productive relationships across organizational levels
  • Cleaning Validation experience is highly preferred

Beneficii

  • Annual bonus opportunity based on company and individual performance
  • Pension plan
  • Private medical insurance
  • Wellbeing programme
  • Flexible benefits programme
  • Comprehensive healthcare programmes
  • Initiatives supporting work-life balance
  • Relocation assistance
  • Flexible working arrangements
  • Remote work options
  • Tax assistance for international colleagues
  • Access to learning resources and training
  • Support for professional development

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