Manufacturing Operations 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.

Requirements

Responsibilities:

• Provide direct support to Process Team Leads across
  Commercial & Clinical products (Small Molecules, Biologicals, Drug
  Substance, Drug Product and Packaging operations on targeted/prioritized
  activities.
  
• Manage and execute all transactional ERP aspects  for production efforts at CMOs (includes
  executing production transactions, updating work order dates, receipting of
  purchase orders, inter organizational transfers etc.)
  
• Own and manage prioritized change controls and deviations
  within the Quality Management System (QMS) to effective on time closure and no
  impact on supply.
  
• Consolidation and issuance of key performance metrics per
  Process Team
  
• Provide back -up support for Process Team Leads where
  necessary (e.g. holidays)
  
• Support selected continuous improvement activities
  aligned to the site business plan objectives with clear and measurable time and
  money savings.
  
• Work cross -functionally to perform rigorous root cause
  analysis, to understand issues and implement corrective actions as appropriate.
  
• Document key business processes in a standard format
  (e.g., Best Practice Document or Standard Operating Procedure).
  
• There may be a need for this person to execute operation
  tasks with a view to eliminating or reducing the number of touchpoints
  associated with a task.
  
• This list of support responsibilities may change
  depending on business needs and employees are expected to be adaptable and
  flexible where this need arises.
  

Experience Required:

• Minimum requirement of 5 years’ experience within an
  Operations and regulated environment.
  
• Relevant 3rd level qualification.
  

Required Skills:

• Will have a working understanding of ERP systems (e.g.
  SAP)
  
• Will have a good working understanding of the
  processes/unit operations assigned to the team.
  
• Ability to engage cross functional teams in the
  resolution of short -term issues and sustained performance for long -term goals.
  
• Experience in lean/six sigma/continuous improvement tools
  and techniques.
  
• Excellent written and verbal communication skills.
  
• A high level of initiative and drive, as well as
  excellent organizational skills, are key role requirements.
  
• Ability to work independently.