QA 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.

Overview:

An amazing opportunity has arisen for a QA Specialist QMS (Quality Management Systems)

This role will be responsible for supporting the Quality Department. Ensure that objectives are effectively achieved consistent with the company requirements to ensure compliance safety and reliable supply to our customers .

Requirements

Skills Responsibilities & Qualification:

• Internal and external inspection and auditing change control management quality systems management GMP training & knowledge management.
  
• Supporting the management of the site Documentation / SOP management systems
  
• Provides compliance contribution to project teams and leads specific projects.
  
• Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
  
• Responds to non-standard requests from customer needs.
  
• Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
  
• Use standard systems including MS Word Excel PowerPoint Outlook SAP and various company and industry specific software such as document tracking work order entry/tracking procurement manufacturing entry/reporting etc.
  
• Presentation compilation and review of data as directed
  
• Provide quality support to the site including training and guidance on the interpretation and implementation of Our Companys Guidelines / Policies and regulatory requirements.
  
• Bachelors degree (or higher) in Chemistry Biology Microbiology Automation Engineering or equivalent
  
• A minimum of 3-4 years experience in Quality Control Quality Assurance or Pharmaceutical or Biological Operations
  
• Knowledge of EU/US quality related pharmaceutical regulations
  
• Basic computer literacy
  
• Strong communication skills
  
• High level of technical aptitude & motivation
  
• Demonstrated initiative and pays attention to detail
  
• Good presentation skills.
  
• Excellent knowledge of relevant Quality and GMP Compliance Guidelines