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Commissioning & Qualification Engineer - Beerse, Belgium
Eingestellt von Elevate Direct
Gesuchte Skills: Engineering, Engineer, Support
Projektbeschreibung
Commissioning & Qualification Engineer - Beerse, Belgium
The function holder:
-Is responsible to maintain the qualification status of systems in support of new, transferred and existing products through definition & maintenance of contemporary methodologies & standards.
- Is responsible for review of System Qualification documents.
- Act as Technical Owner
- Act as Subject Matter Expert for Combination Products within the Qualification Engineering group
- Steers under minimal guidance specialists and contractors within own discipline and/or responsibility area
- Participates in the development of global standards/guidelines, reviews local standards/guidelines
GENERAL ACTIVITIES
-Participate in system and process change projects and assure quality and compliance aspects.
- Participate in system and process introduction projects and assure quality and compliance aspects.
- Identification and remediation of gaps in the qualification files of existing systems.
- Act as a SME (Subject Matter Expert) for the Qualification Engineering impact assessment of the Change Controls.
- Prepare for internal and external inspections.
- Be the spokesperson and Subject Matter Expert during audits and inspections, as pertains Qualification Engineering topics.
- Based on expertise, makes strong recommendations on investigations, investments or projects.
GENERAL ACTIVITIES QUALIFICATION ENGINEERING
-Maintain a current knowledge of international regulations, guidelines and industry practices related to system (process equipment) qualification.
- Generate and maintain the area Validation Master Plans, containing an inventory of all existing systems and their qualification status.
- Report on a periodic basis the System Qualification status (incl VMP completion rate) in the different departments.
- Perform periodic assessments (PSQR) of the overall quality of GMP critical systems and decide upon the need for re-qualification.
- Writing and Review of User Requirement Specifications (URS)
- Review of System Requirement Specifications (SRS)
- Writing and Review to the Qualification Impact Assessment (IA).
- Writing and Review of system qualification documents such as DQ/IQ/OQ - and PQ protocols/reports, QSR.
- Responsible for writing and review of discrepancies occurring during execution of qualification activities.
- Make sure that all deliverables out of qualification are implemented in the Q systems: Master Batch Records, SOPs, Work instructions, Calibration records
- Knowledge of GMP requirements, methodologies, concepts and requirements related to system validation
- FDA - 21 CFR Part 210, 211 Good Manufacturing Practice for Finished Pharmaceuticals
- FDA - 21 CFR Part 11 Electronic records and electronic signatures
- EudraLex, The Rules Governing Medicinal Products in the European Union Volume
- EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use
- European and United States Pharmacopoeia and applicable guidelines.
- Is point of contact to customers for systems and processes within own field of expertise and makes the final technical decision for change
Additional information about the process
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886. This job with Johnson &
Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services.
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, and action that email and your application will be visible to the hiring organisation directly.
The function holder:
-Is responsible to maintain the qualification status of systems in support of new, transferred and existing products through definition & maintenance of contemporary methodologies & standards.
- Is responsible for review of System Qualification documents.
- Act as Technical Owner
- Act as Subject Matter Expert for Combination Products within the Qualification Engineering group
- Steers under minimal guidance specialists and contractors within own discipline and/or responsibility area
- Participates in the development of global standards/guidelines, reviews local standards/guidelines
GENERAL ACTIVITIES
-Participate in system and process change projects and assure quality and compliance aspects.
- Participate in system and process introduction projects and assure quality and compliance aspects.
- Identification and remediation of gaps in the qualification files of existing systems.
- Act as a SME (Subject Matter Expert) for the Qualification Engineering impact assessment of the Change Controls.
- Prepare for internal and external inspections.
- Be the spokesperson and Subject Matter Expert during audits and inspections, as pertains Qualification Engineering topics.
- Based on expertise, makes strong recommendations on investigations, investments or projects.
GENERAL ACTIVITIES QUALIFICATION ENGINEERING
-Maintain a current knowledge of international regulations, guidelines and industry practices related to system (process equipment) qualification.
- Generate and maintain the area Validation Master Plans, containing an inventory of all existing systems and their qualification status.
- Report on a periodic basis the System Qualification status (incl VMP completion rate) in the different departments.
- Perform periodic assessments (PSQR) of the overall quality of GMP critical systems and decide upon the need for re-qualification.
- Writing and Review of User Requirement Specifications (URS)
- Review of System Requirement Specifications (SRS)
- Writing and Review to the Qualification Impact Assessment (IA).
- Writing and Review of system qualification documents such as DQ/IQ/OQ - and PQ protocols/reports, QSR.
- Responsible for writing and review of discrepancies occurring during execution of qualification activities.
- Make sure that all deliverables out of qualification are implemented in the Q systems: Master Batch Records, SOPs, Work instructions, Calibration records
- Knowledge of GMP requirements, methodologies, concepts and requirements related to system validation
- FDA - 21 CFR Part 210, 211 Good Manufacturing Practice for Finished Pharmaceuticals
- FDA - 21 CFR Part 11 Electronic records and electronic signatures
- EudraLex, The Rules Governing Medicinal Products in the European Union Volume
- EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use
- European and United States Pharmacopoeia and applicable guidelines.
- Is point of contact to customers for systems and processes within own field of expertise and makes the final technical decision for change
Additional information about the process
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886. This job with Johnson &
Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services.
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, and action that email and your application will be visible to the hiring organisation directly.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges