Quality Control Systems Specialist

About PSC Biotech

Who 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 cloudbased 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 likeminded 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 diversecultural work setting.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse 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.

Overview:

• The Quality Control (QC) Systems Specialist at the facility will support the QC Laboratory through routine maintenance troubleshooting and repairs of all analytical laboratory instruments in addition to supporting the instrument lifecycle as a whole (installation qualification operation and retirement).
  
• The QC Systems Specialist leads continuous improvement of QC operations through their QC Systems knowledge and areas of expertise.
  
• The QC Lab System team at the facility will ensure that QC objectives are effectively achieved and consistent with the facility requirements to ensure compliance safety and reliable supply to our customers.
  
  

Requirements

Responsibilities:

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

• Responsible for the maintenance of the QC systems and instrumentation in compliance with uptodate 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 QC systems and instrumentation and team priorities.
  
• 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:

Technical:

• Strong experience with analytical instrument maintenance CSV experience beneficial.
  
• Excellent understanding of data integrity compliance requirements.
  
• Demonstrated ability to drive complex tasks to completion.
  
• Strong organizational problemsolving 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 selfmotivation knowledge enthusiasm and drive.
  

Qualifications:

• Third level education in a Science or Engineering related course of study