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
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.

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 Company’s
  Guidelines / Policies and regulatory requirements.
  
• Bachelor's 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