QC Instrumentation Specialist

3 months ago

Dublin, Ireland PSC Biotech Ltd Full time
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 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.



Role Description:

  • The role of Quality Control (QC) Instrumentation Systems Specialist at Dublin operates as part of a dynamic team to plan, execute, and managing 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 is 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 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, CAPA’s and change control’s 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 co-ordinate work to meet a common goal.
  • A high level of self-motivation, knowledge, enthusiasm, and drive.


#LI-XA1


  • Senior Specialist, QC Materials Management, Incoming Components

    7 days ago

    Dublin, Ireland Bristol Myers Squibb Irl Full time

    Working with Us Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...

  • QC SpecialistNew

    3 months ago

    Dublin, Ireland Next Generation Full time

    My client is seeking to recruit a QC Specialist to join their Separations Laboratory, the function of which is to support drug product and drug substance release testing. The successful candidate will be involved in assisting in laboratory operations, performing testing of samples and performing laboratory duties in accordance with cGMP regulations. The...

  • QC Bioanalytical Analyst

    2 days ago

    Dublin, Ireland PSC Biotech Ltd Full time

    Job DescriptionAbout PSC BiotechWho are we?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...

  • QC Bioanalytical Analyst

    3 days ago

    Dublin, Ireland PSC Biotech Ltd Full time

    About PSC BiotechWho are we?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...

  • Lab Technician

    1 month ago

    Dublin, Ireland PSC Biotech Ltd Full time

    About PSC BiotechWho are we?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...

  • Lab Technician

    1 month ago

    Dublin, Ireland PSC Biotech Ltd Full time

    Job DescriptionAbout PSC BiotechWho are we?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...

  • QC Microbiology Analyst

    2 months ago

    Dublin, Ireland PSC Biotech Ltd Full time

    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...

  • QA/QC Officer

    1 month ago

    Dublin, Ireland Suir Engineering Full time

    We have an exciting opportunity for an Electrical QA to join Suir Engineering. This position will be based on a Pharma project in Dublin 15  Here in Suir Engineering we are a leading international provider of innovative Mechanical, Electrical and Instrumentation Engineering Solutions. Our core sectors are Energy, Power and Renewables, Pharma, Food...

  • QC Bioanalytical Analyst

    3 months ago

    Dublin, Ireland PSC Biotech Ltd Full time

    About PSC Biotech Ltd 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...

  • QC Bioanalytical Analyst

    3 months ago

    Dublin, Ireland PSC Biotech Ltd Full time

    Job DescriptionAbout PSC Biotech Ltd 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...

  • QA / QC Engineer (Electrical)

    3 weeks ago

    Dublin, Ireland CJK Electrical Ltd Full time

    Title: QA / QC Engineer (Electrical) Reporting to the Project Manager Duties and Responsibilities: Implementation and maintenance of the CJK Engineering ISO9001:2015 system, on site. Preparation of project specific Project Quality Plans (PQP). Creation of Inspection & Test Plan (ITP) document for scope of works. Development of Quality Control (QC) Test Packs...

  • Lab Systems Specialist

    2 weeks ago

    Dublin, Ireland Headcount Solutions Ltd Full time

    Lab Systems Specialist This position is responsible for providing technical support in the development and maintenance of various QC lab systems user workflows to support various site manufacturing, stability, method transfer and non-routine testing activities This is a Dublin based role within a Biotech Multinational. Key Responsibilities: Create and...

  • Regional Quality Control Lead

    3 weeks ago

    Dublin, Ireland Kirby Group Engineering Full time

    Regional Quality Control Lead - Nationwide Permanent position available with a considerable portfolio of works for the next 5+ years To build your career by assisting in the delivery of 'leading edge' engineering projects. To work with a vibrant, agile and multi-functional team in delivering projects on time, safely, to budget and to the required quality...

  • Graduate Lab Systems Specialist

    2 weeks ago

    Dublin, Ireland PE Global Full time

    PE Global is recruiting for a Graduate Lab Systems Specialist on behalf of our biopharmaceutical client in Dublin. This is an initial 12-month contract role. Position Summary Support of implementation of Maximo to QC laboratories at Cruiserath site. Create and maintain master data/static data in lab systems BIOVIA LES (Laboratory Execution System) and CIMS...

  • Logistics Specialist

    3 months ago

    Dublin, Ireland Ecocem Full time

    Role Description Cement production is responsible for 8% of global CO2 emissions, more than aviation, shipping, and long-haul trucking combined. Ecocem is shaping the future of low carbon cement with ambitions to deliver a 50% cut in CO2 emissions from cement by 2030. As part of our focus on continued growth, we are looking to recruit a Logistics Specialist...

  • Food Safety

    4 months ago

    Dublin, Ireland Musgrave Full time

    Summary Job ref: 15437 Job Type: Location: Dublin Contract type: Permanent Closing Date: 9 July 2024 Food Safety & Quality Technical Specialist - La Rousse Foods We are now hiring a Food Safety & Quality Technical Speciliast in our La Rousse Foods Business to cover the eveninng shift 3.30PM - 11PM (Monday -...

  • Senior Data Manager

    2 days ago

    Dublin, Ireland Real Time Recruitment Full time

    Realtime are hiring for a Senior Data Manager (Director level) to lead and advance the data management initiatives, with a focus on financial instrument data critical to a trading environment. The successful candidate will have at least 10 years of professional experience in financial data management or a trading-related role, with an in-depth understanding...

  • Digital Solution Area Specialist

    1 month ago

    Dublin, Ireland myGwork Full time

    This job is with Microsoft, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Overview Enterprise Digital Specialist...

  • Technical Sales Engineer

    1 week ago

    Dublin, Ireland Bonner Full time

    We are looking to recruit a Technical Sales Engineer to join our expert instrumentation and control team in our Dublin office. Role Are you passionate about innovation, technology and sales? If the answer is yes, BONNERwants you! Were recruiting for a Technical Sales Engineer and in this dynamic role, you'll be at the forefront of driving innovation by...

  • Technical Sales Engineer

    7 days ago

    Dublin, Ireland Bonner Full time

    We are looking to recruit a Technical Sales Engineer to join our expert instrumentation and control team in our Dublin office. Role Are you passionate about innovation, technology and sales? If the answer is yes, BONNERwants you! Were recruiting for a Technical Sales Engineer and in this dynamic role, you'll be at the forefront of driving innovation by...