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Computer Systems Validation Coordinator for R&D - Belgium
Keyrus Biopharma (company)
Posted on : 23 May 2017
We are looking for a Computer Systems Validation Coordinator for one of our clients in Belgium.
Apply the company's R&D validation methodology for laboratory automated equipment qualification in the frame of local infrastructure projects, respecting cGMP (EU, US and all other applicable regulations).
Role and main tasks:
- In the context of investments (new or upgrades) or alignment projects in R&D, ensure proper execution of the company's R&D validation methodology and application of cGMP (Validation Master Plan, URS, RA, Design Qualification, Installation & Operational Qualification, Performance Qualification and Validation Reports) and specific regulations applicable to the “computer” domain (such as FDA’s 21 CFR Part 11 or Eudralex Annex 11).
- Ensure the application of the company's R&D SOPs (such as Change Control, Incidents Management, Access Management, Backup and Restore,…).
- Manage, schedule, coordinate and track each qualification or validation activity to ensure timely completion of the validation plan in coordination with Production, Technical, Quality depts
- Monitor validation deviations to ensure they are properly generated, managed and completed.
- Coach the User, Technical Services, Validation and QA regarding the company's R&D validation methodology applied to automated systems.
- Report significant issues identified to the reporting Manager.
- University level (engineering, automation, IT, biological laboratory equipment…) or equivalent by experience.
- Bilingual French/English (spoken and written)
- Knowledge of main laboratory automation and IT principles and components (PLC, SCADA, HMI, network, spread sheets…)
- Knowledge of process control part of standard automated lab systems, such as (examples):
- Bioreactors / fermentors
- Knowledge of good practices in electronic records management
- Knowledge of risk analysis methods applicable to computerized systems (such as FMEA)
- Good knowledge of projects and qualification steps, including commissioning.
- Planning of activities
- Regulations and standard guidelines :
- Specific regulations and guidelines applicable to computerized systems, such as 21 CFR Part 11 (FDA), Annex 11 (EMEA)
- GAMP 5 on Risk Based Approach to Compliant Computerized Systems
- ASTM 2500 - ICH Q9 on Quality Risk Management
- Needs to demonstrate success in implementing CSV discipline in minor or major projects
- At least three years experience in CSV applied ideally in an R&D or QC lab environment
- Quality oriented
- Good skills in validation activities : organization, understanding and implementation of validation practices in projects, time schedules etc.
- Coaching, team working and communication skills are key
- Good knowledge in project coordination
- Good expertise in GMP Practices
- Ability to work under heavy pressure due to the requested flexibility and reactivity of the activities
- Autonomous manager, who also has the ability to work in project teams in a multidisciplinary environment and a matrix organization
- Experience as suppliers’ auditor would be an advantage
What we offer
- You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…).
- Each employee will be welcomed with a varied integration program.
- We invest considerable time and resources in training our staff (technical and non-technical courses).
- You will join a dynamic and international environment with enthusiastic and professional colleagues.
Who We are
- Our company is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence.
- Our ‘human’ approach to service provision is what differentiates us from our competitors.
- Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
- We’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
- From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Bio statistics, Medical Writing & Medical Information, Real World evidence services.