Quality Assurance Manager of VHIOâs clean room (VHIO)
Quality Assurance Manager of VHIOâs clean room (VHIO)
Posted on :
22-05-2025
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1 Vacancy
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Job Description
Reporting to the Clean Room Advanced Therapies Medicinal Products (ATMPs) Qualified Person. The mission of the role will be to implement control and maintain the GMP Quality Assurance System of the Advanced Therapies Accelerator Unit at VHIO. The position is funded by the Advanced Therapies Accelerator AECC Excellence Program.
Education and qualifications:
Required:
- University degree in biosanitary fields (Pharmacy Biology Chemistry Biotechnology and related areas).
- Fluency in Catalan Spanish English (business level).
Experience and knowledge:
Required:
- Demonstrable experience/references in quality system management preferably in manufacturing processes for humanuse medicines or similar (GMPs).
- Demonstrated and/or regulated knowledge in Good Manufacturing Practices (GMPs) and/or specific Good Manufacturing Practices for Advanced Therapy Medicinal Products (GMPATMPs).
Desired:
- Knowledge of regulations and applicable standards for Advanced Therapy Medicinal Products in Europe and Spain.
Main responsibilities and duties:
Ensuring compliance with the GMPATMPs Standards in the Advanced Therapies Accelerator Units manufacturing activities regarding document management creation followup and evaluation of nonconformities/incidences change controls and risk assessment. Also monitoring of training and of the validations and qualifications performed to comply with the responsibilities and qualifications described in current GMPs regulations.
- Quality Assurance: Responsible for monitoring and maintaining the quality management system under the responsibility of the Technical Responsible. In general responsible for ensuring compliance with GMPATMPs in the manufacturing activities of the Unit/organization.
- In terms of document management: maintaining the quality documentation system creation followup and evaluation of nonconformities changes and risks as well as monitoring training and validations/qualifications executed.
- Establishment and Monitoring of the Process Validation: IQ OQ PQ.
- Establishment of the Internal Audit System: Planning and execution.
- Establishment of the Training System: Planning and execution.
- Establishment of the Equipment Control Plan: Calibrations and Qualifications.
- Monitoring and maintenance of the Validation Master Plan.
- Monitoring and maintenance of incidences deviations outofspecifications investigations change controls validations qualifications and risk and followup of Corrective/Preventive Actions.
- Provides QA support to manufacturing packaging processes and batch release to the Technical Responsible.
- Assists with external audits (Regulatory Agencies Certification Bodies clients or interested parties) in collaboration with affected or involved Areas/Departments.
- Guarantee the harmonization and effectiveness of the global quality system/elements (QMS) throughout the company and departments (R&D Production QC Management) providing an overall view of quality assurance.
Labour conditions:
- Fulltime position: 40h/week.
- Starting date: immediate.
- Gross annual salary:euros /// (Salary ranges are consistent with our Collective Agreement pay scale).
- Contract: Technical and scientific activities contract linked to the project
What can we offer
- Incorporation to Vall dHebron Research Institute (VHIR) a public sector institution that promotes and develops the biomedical research innovation and teaching at Vall dHebron University Hospital (HUVH) the biggest hospital of Barcelona and the largest of Catalan Institute of Health (ICS).
- A scientific environment of excellence highly dynamic where highend biomedical projects are continuously developed.
- Continuous learning and a wide range of responsibilities within a stimulating work environment.
- Individual training opportunities.
- Flexible working hours.
- 23 days of holidays 9 personal days.
- Flexible Remuneration Program (including dining checks health insurance transportation and more)
- Corporate Benefits: platform through which you can obtain significant discounts on travel culture technology gastronomy sports... among many others.
- Healthy Offering: choose from a variety of wellbeing focused activities to be the healthiest you.
Deadline to apply:
VHIR embraces Equality and Diversity. As reflected in our values we work toward ensuring inclusion and equal opportunity in recruitment hiring training and management for all staff within the organization regardless of gender civil status family status sexual orientation gender identity and expression religion age functional diversity or ethnicity.
Employment Type
Full Time
Key Skills
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