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Quality Assurance Specialist
Eingestellt von Berkley IT
Gesuchte Skills: Engineering, Sap
Projektbeschreibung
BERKLEY ENGINEERING ARE CURRENTLY SEEKING EXPERIENCED QUALITY ASSURANCE SPECIALISTS FOR 6-12 MONTH CONTRACTS WITH OUR PHARMACEUTICAL MANUFACTURING CLIENT IN DUBLIN
KEY RESPONSIBILITIES:
* Collaborate with cross functional team to deliver project deliverables on time, on budget, and with Quality requirements being met
* Review and edit project documentation ensuring that Quality requirements are met
* Provide QA approval on finalized project documentation
* Contribute to equipment and process risk assessments
* Provide QA oversight for equipment qualification and commissioning activities including but not limited to factory acceptance testing and site acceptance testing
* Evaluate validation protocol content and execution
* Is a champion for safe working practices and safety initiatives within their area
BASIC QUALIFICATIONS
* University degree. Engineering or Science related discipline preferred
* Significant experience (10yrs +) working in the pharmaceutical or biotechnology industry
PREFERRED QUALIFICATIONS
* Excellent written and verbal communication skills
* Experience working with dynamic cross-functional teams and influencing decisions
* Experience working in aseptic operations, protein formulation, syringe filling
* Experience working with isolator and e-beam technology
* Experience with ASTM 2500 approach to equipment commissioning and qualification
* Understanding/experience with Trackwise, Change Control Management System, EDMQ and SAP
* Knowledge of applicable Regulatory requirements
* Experience with Regulatory inspections
* Operational Excellence experience
Berkley Engineering is a specialist recruitment consultancy which recruits pharmaceutical, medical device and clinical professionals throughout Ireland, Asia, UK and Australia
WE ARE ACTING AS AN EMPLOYMENT BUSINESS.
KEY RESPONSIBILITIES:
* Collaborate with cross functional team to deliver project deliverables on time, on budget, and with Quality requirements being met
* Review and edit project documentation ensuring that Quality requirements are met
* Provide QA approval on finalized project documentation
* Contribute to equipment and process risk assessments
* Provide QA oversight for equipment qualification and commissioning activities including but not limited to factory acceptance testing and site acceptance testing
* Evaluate validation protocol content and execution
* Is a champion for safe working practices and safety initiatives within their area
BASIC QUALIFICATIONS
* University degree. Engineering or Science related discipline preferred
* Significant experience (10yrs +) working in the pharmaceutical or biotechnology industry
PREFERRED QUALIFICATIONS
* Excellent written and verbal communication skills
* Experience working with dynamic cross-functional teams and influencing decisions
* Experience working in aseptic operations, protein formulation, syringe filling
* Experience working with isolator and e-beam technology
* Experience with ASTM 2500 approach to equipment commissioning and qualification
* Understanding/experience with Trackwise, Change Control Management System, EDMQ and SAP
* Knowledge of applicable Regulatory requirements
* Experience with Regulatory inspections
* Operational Excellence experience
Berkley Engineering is a specialist recruitment consultancy which recruits pharmaceutical, medical device and clinical professionals throughout Ireland, Asia, UK and Australia
WE ARE ACTING AS AN EMPLOYMENT BUSINESS.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
SAP Entwicklung, Ingenieurwesen/Technik