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Qualification - Validation - Engineer - GMP - EHS - SOX - CSV
Eingestellt von Sentinel IT LLP
Gesuchte Skills: Support, Engineer
Projektbeschreibung
Qualification - Validation - Engineer - GMP - EHS - SOX - CSV
Activities:
- Co-ordinate and manage qualification aspects of technical projects associated with the full life cycle of system specification
- Complete test/qualification and provide ongoing support, such as execution of appropriate event impact assessments, and support of modifications within Pharma (parenterals & base), MD&D, Chemicals, Utilities, IM/IT and LAB
- Offer support to interdepartmental clients and witness the execution of critical qualification/validation steps if required
- Contribute to scheduling of PQ activities
- Assure review for compliance and approval of all critical qualification deliverables/documentation (QP, URS, IA, DQ, IQ, OQ, PQ, P&ID schemata & PM-Plans) as determined in system Qualification/Validation Plans
- Assure formal communication of a completed system qualification to representative Quality Assurance department by means of an Qualification Summary Report (QSR)
- For new equipment assure the existence of full life cycle qualification documents
- Assure archiving of all qualification documents is completed correctly
Profile:
- Understanding of compliance with the GMP, EHS and SOX requirements and guidelines, which are connected to the respective function
- Higher degree as engineer or pharmacy technician
- Minimum 5 years of experience in pharmaceutical or medical device area
- Excellent knowledge of GMP requirements. Preferably CSV expert
- Fluent in German and English
Activities:
- Co-ordinate and manage qualification aspects of technical projects associated with the full life cycle of system specification
- Complete test/qualification and provide ongoing support, such as execution of appropriate event impact assessments, and support of modifications within Pharma (parenterals & base), MD&D, Chemicals, Utilities, IM/IT and LAB
- Offer support to interdepartmental clients and witness the execution of critical qualification/validation steps if required
- Contribute to scheduling of PQ activities
- Assure review for compliance and approval of all critical qualification deliverables/documentation (QP, URS, IA, DQ, IQ, OQ, PQ, P&ID schemata & PM-Plans) as determined in system Qualification/Validation Plans
- Assure formal communication of a completed system qualification to representative Quality Assurance department by means of an Qualification Summary Report (QSR)
- For new equipment assure the existence of full life cycle qualification documents
- Assure archiving of all qualification documents is completed correctly
Profile:
- Understanding of compliance with the GMP, EHS and SOX requirements and guidelines, which are connected to the respective function
- Higher degree as engineer or pharmacy technician
- Minimum 5 years of experience in pharmaceutical or medical device area
- Excellent knowledge of GMP requirements. Preferably CSV expert
- Fluent in German and English
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges