CSV Compliance Engineer

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:

The Compliance Engineer will be responsible for supporting DMO Compliance activities at the single use multi-product.

Requirements

Responsibilities:

• Ensure permanent inspection readiness within the DMO team.
  
• Support generation/review/approval of CSA deliverables.
  
• Providing ongoing compliance (GxP Financial Data Privacy) coaching and support to all team members.
  
• Manage deployment of Global SDLC/CSA and IT Security policies and procedures.
  
• Ensure supply of all compliance components required to deliver high quality product through tactical planning and execution of project and compliance deliverables including change-control periodic reviews performance monitoring system administration access administration disaster recovery deviations incident problem management/investigations CAPAs audits policy deployment cyber security data integrity EHS training etc.
  
• Ensure highest Quality EHS & Compliance standards.
  
• Active participation in the Tier process and proactively resolving issues.
  
• Liaise with Compliance Engineers from other areas and support Site Quality Council and other site quality initiatives.
  
• Coordinate AIT Change-controls EHS activities and EHS/Quality metrics
  
• Completion of AIT Investigations root-cause analysis and CAPAs
  
• Strong project management skills to support project delivery and operational readiness.
  

Experience Knowledge & Skills:

• At least 2 years experience in the planning document generation support or execution of CSV activities in a biologic drug substance manufacturing plant.
  
• A thorough knowledge of regulatory requirements associated with computer systems including EU GMP Annex 11 21 CFR Part 11 is required.
  
• Strong knowledge in Data Integrity (MHRA Data Integrity Definitions and Guidance for Industry and PIC/S Guidance Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments).
  
• Experience in PLC/SCADA/DCS systems
  

Qualifications & Education:

• Degree qualification (Science Engineering Technical).
  
• Preference for Lean Six Sigma Green Belt.
  
• Desirable to have qualification in Project Management and Computer Validation.
  
• Very Strong Collaboration Compliance and Communication Skills