Quality Assurance Operations NPI 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 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 clients expectations with regards to quality of all scalable and business unit deliverables staying under budget and ensuring timelines for our deliverables are being met.

An exciting opportunity has arisen for a Quality Assurance Operations NPI Specialist in Co. Dublin. The role ensures that the New Product Introduction objectives are effectively achieved consistent with the companys requirements to ensure compliance safety and reliable supply to our customers as well as meeting Health Agency regulations and all other applicable governing regulations.

With energy knowledge & innovation the QA NPI Specialist will:

• Review and approve change controls corrective and preventive actions (CAPAs) deviations including investigation protocols root cause analysis and final investigation reports.
  
• Review and approve batch records
  
• Review and approval of Equipment qualification including IOQ and PQ process validation development studies hold time studies quality assurance support across functional and cross-functional forums.
  
• Oversee quality aspects of material and supplier management including preparation of material qualification packages supplier audit assessments and maintenance of the supplier management system.
  
• Collaborate with stakeholders such as Quality Control (QC) Manufacturing Science & Technology (MS&T) Engineering and Warehouse to develop review and maintain documentation and quality records throughout the product lifecycle (e.g. method validations facility upgrades qualification protocols calibration records).
  
• Review and approve Good Manufacturing Practice (GMP) documentation and data to ensure accuracy completeness and compliance.
  
• Partner cross-functionally to support timely delivery of project milestones.
  
• Contribute to the identification development and execution of continuous improvement initiative and action plans with cross-functional teams.
  

Requirements

Experience Knowledge & Skills

General

• A self-starter and results-focused the successful candidate will have strong contemporary knowledge of relevant cGMPs regulations and current industry trends.
  
• Strong collaboration and cross-functional leadership skills.
  
• Strong verbal and written communication skills project management skills.
  
  

Technical

• Strong knowledge of qualification and implementation of Single Use technologies and raw materials and supplier qualifications for use in a GMP environment.
  
• Strong contemporary knowledge of relevant cGMPs regulations and current industry trends.
  
• Proven track record in delivering excellence.
  
• Competency in the use of SAP KNEAT eVal and Veeva systems including change control is an advantage.
  
• Familiarity and participation in risk assessment processes
  
  

Education & Experience

• Bachelors degree (or higher) in Chemistry Biology Microbiology Engineering or Supply Chain in a relevant discipline.
  
• 5 to 8 years experience in Quality Control Quality Assurance or Pharmaceutical Vaccine or Biological Operations or Technical Operations.