Quality Control Planner

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.

The QC planner supports the planning of QC activities in the QO Laboratory from the start to end planning (sample receipt to release) including capacity models. This includes demands from multiple centres production ility release PPQ contract lab testing all incoming samples including contract lab testing and adhoc testing as required.

This is a day role based on site (Monday to Friday).

• Create a rolling QC plan based on the laboratory workload and known constraints such as the QC equipment qualification status calibrations and maintenance plans personnel availability and training on the techniques. The plan includes personnel and equipment ignment and the expected sample schedule.
  
• ess QC Laboratory capacity (internal and contract labs) based on demand from multiple work centres centres production ility release PPQ contract lab testing all incoming samples including contract lab testing and adhoc testing as required
  
• Liaise with logistics and warehouse personnel to communicate the incoming/outgoing sample schedule.
  
• Monitor plan ess cycle time adherence report KPIs yse root causes if/when required and propose mitigation plans if required.
  
• Review mid to longterm site plans perform scenario planning based on product and process changes test od changes compliance commitments staffing levels and equipment capability. Summarise potential laboratory bottlenecks and propose resolutions to ensure continued laboratory capability.
  
• Monitor and summarise the contract laboratory servicelevel performance against the agreements and the igned work. Escalate to contract owner if agreed service level is not achieved.
  
• Initiates manages coordinates change controls and deviations for the QC department as required. Facilitating investigations (leading where required) ensuring effective Root Cause ysis and CAPAs are implemented
  
• Be an advocate for continuous improvement.
  
• Drive metrics that appropriately and accurately measure QC performance and take action to mitigate as required.
  
• Apply project management concepts and techniques as they relate to planning and test od to meet elished delivery timeline
  

Requirements

• Strong collaboration and crossfunctional leadership ss to drive continuous improvement and promote knowledge sharing and implementation of best practices across the site.
  
• Demonstrated ability to make and act on decisions while balancing speed quality and risk.
  
• Ability to work crossfunctionally and manage relationships with stakeholders.
  
• Interpret and summarise data deal with uncertainty manage complexity and communicate concisely