Cleaning Support Specialist

About PSC Biotech

Who we are

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 cloudbased 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 points which includes the opportunity to work with the most talented cohort of likeminded 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 diversecultural work setting.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse 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.

A fantastic career opportunity has arisen for a Cleaning Support Specialist.

Requirements

Bring energy knowledge innovation to carry out the following:

• Responsible for issuing and management of cleaning changes and documentation.
  
• Responsible for reviewing and incorporating relevant updates as communicated via the Technical Team Lead.
  
• Responsible for management and tracking of Cleaning validation parameters and commitments.
  
• Support for Cleaning Investigations
  
• Compilation of CPV reports CAR and APRs
  
• Ownership and management of changes.
  
• Generation and tracking of cleaning campaign documentation.
  
• Stewardship of validated campaign data.
  
• Liaising with product teams to align turnaround targets.
  
• Investigation support for Cleaning QNs.
  
• Assessments of OOTs.
  
• Support project assignments as required.
  
• Completion of validation reports.
  

What skills you will need:

In order to excel in this role you will more than likely have:

• Degree qualification in a science or engineeringrelated discipline.
  
• Knowledge of GMP standards.
  
• Good communication skills both written and verbal.
  
• Strong technical writing skills.
  
• Previous experience in API or Drug Product manufacturing is desirable.
  

• To maintain accurate records in compliance with GMP expectations.
  
• To understand and internalise procedures relevant to GMP operations.
  
• To communicate clearly and concisely on technical issues.
  
• To deliver project goals on time.
  

• Demonstrated ability to work as part of a diverse team in an inclusive manner.
  
• High personal integrity credibility and energy.
  
• Must be motivated and focused with a demonstrated ability to be selfdriven.
  
• Communication written oral
  

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