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Process Automation Csv, Meath, Psc Biotech Ltd

Ireland, Ireland, Meath
Published 2022-09-22
Expires 2022-10-22
ID #1178169206
Free
Process Automation Csv, Meath, Psc Biotech Ltd
Ireland, Ireland, Meath,
Published September 22, 2022

Job details:

Job type: Full time
Contract type: Permanent
Salary type: Monthly
Occupation: Process automation csv


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Description

Job Description About PSC Biotech  Who we are?   PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.  This role will manage all equipment and system validation activities for the cGMP manufacture of biological bulk drug substances. The Qualification Engineer will provide equipment / system process engineering and validation expertise to support the facility start-up and routine commercial manufacturing.  Generate/ update, execute, review and approve Computer System Validation (CSV) documentation deliverables as part of a multi-disciplinary team of  representatives responsible Process Automation Remediation Plan delivery. Responsibilities include: Generate/ update, execute, review and approve Computer System Validation (CSV) deliverables in line with the Process Automation Remediation Plan delivery. Investigate and trouble shoot problems which occur to determine solutions or recommendations for improvements or change. Work with the system owners and Quality team to ensure that the appropriate Quality standards are applied for all CSV documents and deliverables, consistent with best practice and internal Quality Standards and expectations. Provide technical support for the development of electronic data review procedures Actively manage the execution of all CSV testing with right first time approach. Ensure that any changes in detailed timelines are escalated in a timely manner so that impacts can be proactively assessed and KPI’s maintained. Requirements At least 2 years experience in the planning, document generation, support or execution of CSV activities in a biologic drug substance manufacturing plant. A thorough knowledge of regulatory requirements associated with computer systems including EU GMP Annex 11, 21 CFR Part 11 is required. Strong knowledge in Data Integrity (MHRA Data Integrity Definitions and Guidance for Industry and PIC/S Guidance Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments). Experience in PLC/SCADA/DCS systems #LI-AP1 Requirements At least 2 years experience in the planning, document generation, support or execution of CSV activities in a biologic drug substance manufacturing plant. A thorough knowledge of regulatory requirements associated with computer systems including EU GMP Annex 11, 21 CFR Part 11 is required. Strong knowledge in Data Integrity (MHRA Data Integrity Definitions and Guidance for Industry and PIC/S Guidance Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments). Experience in PLC/SCADA/DCS systems

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    Registered on October 7, 2017

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    Manufacturing is the production of merchandise for use or sale using labour and machines, tools, chemical and biological processing, or formulation. The term may refer to a range of human activity, from handicraft to high tech, but is most commonly applied to industrial production, in which raw materials are transformed into finished goods on a large scale. Such finished goods may be sold to other manufacturers for the production of other, more complex products, such as aircraft, household appliances, furniture, sports equipment or automobiles, or sold to wholesalers, who in turn sell them to retailers, who then sell them to end users and consumers.


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