QC Instrumentation Specialist

6 days ago

Dublin, Dublin City, Ireland PSC Biotech Full time
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.

'Take your Career to a new Level'

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points 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 through 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.

Role Description:

- The role of Quality Control (QC) Instrumentation Systems Specialist at Dublin operates as part of a dynamic team to plan, execute, and manage the activities required to maintain the testing infrastructure of the QC lab.
- The team working style is one of collaboration, coaching, and teamwork to provide Quality oversight and expertise to the QC team to support a High Performing Organisation.
- Our Quality Control group ensures all materials used for our products are manufactured, processed, tested, stored, and distributed aligned with our incredibly high standards of quality, meeting all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers, and suppliers we create a global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Requirements

Role Functions:

The QC Instrumentation Specialist roles and responsibilities include but are not limited to the following:

- Responsible for the qualification, maintenance, and/or integration of the QC systems, in compliance with up-to-date data integrity, regulatory, and industry standards.
- Responsible for change control process and mechanisms required to maintain a state of continued compliance for the QC systems and instrumentation.
- Support the QC department for troubleshooting, investigations, and deviations as an SME.
- Manage deviations, CAPAs and change controls related to the QC and team priorities.
- Assist with implementation of client Quality Chapters to ensure we maintain best practices and build excellence into our QC systems and processes.
- Author and revise local SOPs, work instructions, and guidelines.
- Serve as an SME for regulatory and internal inspections and audits.
- Motivation to be an inspiring member of a high performing team with the desire to continuously learn, improve, and develop.

Experience, Knowledge & Skills:

Typical Minimum Education:

- A bachelor's degree in Engineering, biological science, or related field.

Typical Minimum Experience:

- 3 years' experience in CSV and/or CQV for laboratory systems and instrumentation.
- Experience in regulatory audits.
- Working knowledge of biologics analytical methods and specifications and Good Manufacturing Practice (GMP).

Qualifications & Education:

Technical:

- Strong CSV experience with analytical instrument maintenance.
- Excellent understanding of data integrity compliance requirements.
- Demonstrated ability to drive complex tasks to completion.
- Strong organizational, problem-solving, and continuous improvement skills.

Business:

- Ability to prioritize activities in line with the maintenance schedules and business needs.
- Ability to maintain the flexibility to react to changing business needs.
- Experience and understanding of the change management requirements of validated systems and software.
- Excellent communication skills both verbal and written.

Leadership:

- Ability to handle multiple projects and deliver on critical deadlines.
- Demonstrated ability to work independently on own initiative and manage time.
- Demonstrate ability to work with a team and coordinate work to meet a common goal.
- A high level of self-motivation, knowledge, enthusiasm, and drive.

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