QC Instrumentation Maintenance Specialist

2 weeks ago

Dublin, Dublin City, Ireland PSC Biotech Full time
QC Instrumentation Maintenance Specialist
  • Industry Pharma/Biotech/Clinical Research
  • Work Experience 1-3 years
  • City Dublin
  • State/Province Dublin
  • Country Ireland
Job Description

bout 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.

'Take your Career to a new Level'

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the "heartbeat" of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client's expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Job Title: QC Instrumentation Maintenance Specialist

Role Description:

· The role of Quality Control (QC) MaintenanceInstrumentation Systems Specialist at Dublin operates as part of a dynamic teamto plan, execute, and managing the activities required to maintain the testinginfrastructure of the QC lab.

· The team working style is one of collaboration,coaching, and teamwork to provide Quality oversight and expertise to the QCteam to support a High Performing Organisation.

· Our Quality Control group ensures all materialsused for our products is manufactured, processed, tested, stored, anddistributed aligned with our incredibly high standards of quality, meeting allregulatory requirements.

Requirements

Role Functions:

· Responsible for the maintenance of the QCsystems and instrumentation, in compliance with up-to-date data integrity,regulatory, and industry standards

· Responsible for change control process andmechanisms required to maintain a state of continued compliance for the QCsystems and instrumentation.

· Support the QC department for troubleshooting,investigations, and deviations as an SME.

· Manage deviations, CAPA's and change control'srelated to QC systems and instrumentation and team priorities.

· Author and revise local SOPs, work instructions,and guidelines.

· Serve as an SME for regulatory and internalinspections and audits.

· Motivation to be an inspiring member of a highperforming team with the desire to continuously learn, improve, and develop.

Experience, Knowledge & Skills:

· A bachelor's degree in engineering, biologicalscience, or related field.

· 3 years' experience in CSV and/or CQV forlaboratory systems and instrumentation

· Experience in regulatory audits.

· Working knowledge of biologics analyticalmethods and specifications and Good Manufacturing Practice (GMP).

Qualifications & Education:

Technical:

· Strong CSV experience with analytical instrumentmaintenance

· Excellent understanding of data integritycompliance requirements

· Demonstrated ability to drive complex tasks tocompletion.

· Strong organizational, problem-solving, andcontinuous improvement skills

Business:

· Ability to prioritize activities in line withthe maintenance schedules and business needs.

· Ability to maintain the flexibility to react tochanging business needs.

· Experience and understanding of the changemanagement requirements of validated systems and software.

Leadership:

· Ability to handle multiple projects and deliveron critical deadlines.

· Demonstrated ability to work independently onown initiative and manage time.

· Demonstrate ability to work with a team andco-ordinate work to meet a common goal.

· A high level of self-motivation, knowledge,enthusiasm, and drive.

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