Quality Control Technical Specialist

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.

Description:

QC Technical Services - Equipment Support Role

Overview:

• Responsible for planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities.
  
• Responsible for ensuring that all maintenance & calibration activities carried out by Calibration Technicians are tracked & managed through the Computerised Maintenance Management System (CMMS) Maximo.
  
• Responsible for authoring/owning and approving Validation Life Cycle documents for computer related systems including responsibility for Data Integrity testing and business administration of Laboratory Computer Related systems. Responsible for the execution of protocols once approved.
  

Candidate should have specific hands-on laboratory equipment lifecycle and validation experience.

Key Responsibilities include:

Planning and conducting routine calibration, requalification and maintenance of laboratory equipment ensuring calibration and maintenance schedules are adhered to as per CMMS Maximo. Reviewing & filing of QC calibration & maintenance documentation.

Planning, executing and documenting the qualification of new laboratory equipment in a cGMP regulated environment, including the writing of equipment validation protocols and associated summary reports.

Conduct periodic reviews of instrument validation as part of validation life cycle.

Alerting Quality Control Management in the event of equipment failing to meet calibration or qualification requirements and conducting impact assessments/investigations as required.

Scheduling and coordination of equipment repairs and maintenance with vendors/contractors, while minimizing level of down-time for lab equipment, and disruption to laboratory activities.

Participation in technical project teams to act as a subject matter expert on instrument validation regulations and procedures.

Where applicable, owns and project manages change controls and adherence to Change Control metrics.

Supporting and managing the addition of project components to CMMA Maximo.

Act as a key contributor and sponsor to Data Integrity Assessments for Lab systems.

Any other tasks/projects assigned as per manger s request.

Requirements

Knowledge and Experience:

Bachelor s degree in a Science related field is required.

Minimum of 3 years of laboratory experience in a cGMP laboratory environment including exposure to analytical instrument validation and data integrity assessments.

Detailed knowledge of the methodology, and instrumentation and analytical techniques used for biopharmaceutical testing.

Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity.

Demonstrated success in managing an equipment qualification or maintenance program advantageous.

The successful candidates will be involved with routine activities and may be requested to support project work.

For the most part project work consists of the introduction and qualification of analytical equipment for use in routine QC analysis and the candidate should have specific hands-on laboratory equipment lifecycle and validation.

#LI-DM1

Knowledge and Experience: Bachelor s degree in a Science related field is required. Minimum of 3 years of laboratory experience in a cGMP laboratory environment including exposure to analytical instrument validation and data integrity assessments. Detailed knowledge of the methodology, and instrumentation and analytical techniques used for biopharmaceutical testing. Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity. Demonstrated success in managing an equipment qualification or maintenance program advantageous. The successful candidates will be involved with routine activities and may be requested to support project work. For the most part project work consists of the introduction and qualification of analytical equipment for use in routine QC analysis and the candidate should have specific hands-on laboratory equipment lifecycle and validation. #LI-DM1