Quality Control Planner

4 weeks ago

Carlow, Ireland PSC Biotech Ltd Full time
Job Description

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 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 Overview

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, stability, release, PPQ, contract lab testing all incoming samples, including contract lab testing and ad-hoc testing as required.

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



Responsibilities

  • 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 assignment, and the expected sample schedule.
  • Assess QC Laboratory capacity (internal and contract labs) based on demand from multiple work centres – centres production, stability, release, PPQ, contract lab testing all incoming samples, including contract lab testing and ad-hoc testing as required
  • Liaise with logistics and warehouse personnel to communicate the incoming/outgoing sample schedule.
  • Monitor plan execution – assess cycle time adherence, report KPIs, analyse root causes if/when required, and propose mitigation plans if required.
  • Review mid to long-term site plans – perform scenario planning based on product and process changes, test method 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 service-level performance against the agreements and the assigned 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 Analysis 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 method execution, to meet established delivery timeline


Requirements
Experience, Knowledge & Skills:
  • Strong collaboration and cross-functional leadership skills 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 cross-functionally and manage relationships with stakeholders.
  • Interpret and summarise data, deal with uncertainty, manage complexity and communicate concisely

Qualifications:
  • Degree (or higher) in Science, Engineering or in a relevant discipline, with operational excellence in GMP environment
  • Experience in planning and project management
  • A minimum of 2-3 years’ experience in Quality Control, Quality Assurance or Pharmaceutical or Biological Operation



Requirements
Bring energy, knowledge, innovation and leadership to carry out the following: Lead SAP master data build and data approval activities including hypercare, sustainment materials build, BOMs and Recipes. Participate daily on cross-functional teams collaboratively and actively to address compliance issues and achieve project milestones. Support implementation and training for site Quality Systems and site GMP readiness activities. Support creation, maintenance and continuous improvement of Quality Management Systems (QMS) and associated documentation. Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the start-up facility. Support other QA colleagues, as required. Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture. Support gathering of site metrics Ensure the escalation of risks to management in a timely manner.

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