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Validation Expert
Eingestellt von Computer Futures - London & S.E(Permanent and Contract)
Projektbeschreibung
We are currently searching for a Computer Validation Expert to join my client's Basel based pharmaceutical company on a contract basis. The position is initially for 12 months, commencing in January.
The purpose of this role is to coordinate activities with system owners, QA and system users. This is a part time position, for 20 hours per week.
DAY TO DAY TASKS:
- GMP training according to quality system and training concepts.
- Analogous DQP training for pre-defined systems.
- HSE training.
- Writing SOPs, e-SOPs.
- Generation of GMP document codes.
- Requests via IT ticketing tool.
- System administration for computerised systems.
- Creation of analytical templates/protocols.
- Troubleshooting, repairs, changes to analytical systems and system-specific data Servers.
- Authoring IQ and OQ/PQ test plans, Q reports.
- Coordination of external service and repairs.
WHAT WE NEED FROM YOU:
- 3+ years' experience in computerized system validation, instrument or software validation, or a related area within a regulated industry.
- General knowledge of GxP, 21CFRPart11, Annex 11, or knowledge in other quality systems.
- Excellent communication in English AND German.
If you feel as though you would be good for this role, apply with your CV today!
STHREE ARE COMMITTED TO ENSURING EQUAL OPPORTUNITIES, FAIRNESS OF TREATMENT, DIGNITY, WORK-LIFE BALANCE AND THE ELIMINATION OF ALL FORMS OF DISCRIMINATION IN THE WORKPLACE FOR ALL STAFF AND JOB APPLICANTS. WE WELCOME APPLICATIONS FROM ALL SUITABLY QUALIFIED PERSONS, REGARDLESS OF THEIR RACE, SEX, DISABILITY, RELIGION/BELIEF, SEXUAL ORIENTATION OR AGE.
The purpose of this role is to coordinate activities with system owners, QA and system users. This is a part time position, for 20 hours per week.
DAY TO DAY TASKS:
- GMP training according to quality system and training concepts.
- Analogous DQP training for pre-defined systems.
- HSE training.
- Writing SOPs, e-SOPs.
- Generation of GMP document codes.
- Requests via IT ticketing tool.
- System administration for computerised systems.
- Creation of analytical templates/protocols.
- Troubleshooting, repairs, changes to analytical systems and system-specific data Servers.
- Authoring IQ and OQ/PQ test plans, Q reports.
- Coordination of external service and repairs.
WHAT WE NEED FROM YOU:
- 3+ years' experience in computerized system validation, instrument or software validation, or a related area within a regulated industry.
- General knowledge of GxP, 21CFRPart11, Annex 11, or knowledge in other quality systems.
- Excellent communication in English AND German.
If you feel as though you would be good for this role, apply with your CV today!
STHREE ARE COMMITTED TO ENSURING EQUAL OPPORTUNITIES, FAIRNESS OF TREATMENT, DIGNITY, WORK-LIFE BALANCE AND THE ELIMINATION OF ALL FORMS OF DISCRIMINATION IN THE WORKPLACE FOR ALL STAFF AND JOB APPLICANTS. WE WELCOME APPLICATIONS FROM ALL SUITABLY QUALIFIED PERSONS, REGARDLESS OF THEIR RACE, SEX, DISABILITY, RELIGION/BELIEF, SEXUAL ORIENTATION OR AGE.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges