Senior QA IT Quality Specialist R6505

About PSC Biotech Ltd

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 cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

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 like-minded professionals operating in the Pharma/ Biotech Industry. Our client is currently looking for a highly talented professional to join their team on a permanent basis with an attractive benefits package.

Employee Value Proposition

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.

Our client is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our outstanding ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Our medicines and pipeline are crafted to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases. Our mission is to use the power of science to bring new medicines to our patients.

Summary:The Sr QA IT Quality Specialist is responsible for ensuring that the QA IT Quality group is operating in compliance with Regulatory requirements and the client s internal procedures as well being the key liaison between the IT and Quality Assurance groups.

Essential Duties and Responsibilitiesinclude, but are not limited to, the following:

• Supporting the Data Governance Program
  
• Experienced Technical writer to support procedural and cultural control creation/updates
  
• Experience in deviation and investigation writing and data review
  
• Capable of managing a large program using project management skills
  
• Experience of IT and IT Infrastructure operations
  
• Reviews validation documentation related to projects/change controls.
  
• Manages QA IT related change controls and supports other compliance related tasks e.g. non-conformances
  
• Participates in the review of current and future CSV procedures and polices
  
• Generate/review/Approval of documentation, such as SOPs
  
• Ability to work on own initiative
  
• Experience in data integrity / 21 CFR Part 11 and generation of assessments and remediation activities.
  
• Ability to liaise with numerous departments
  
• Shows focus & a consistent approach to the role and tasks.
  
• Excellent people skills
  
• Ensure Training is maintained and current.
  
• Follow all EHS/Safety SOP/Policies
  
• Actively look for Continuous improvements
  
• Ensures IT procedures are in compliance with regulatory requirements
  
• Ensures IT are operating in compliance with regulations and procedures
  
• Assists IT in interactions with Quality Assurance personnel and the Quality Management System
  
• Evaluates, Develops and Modifies Policies and Standard Operating Procedures to meet regulatory requirements and obligations
  
• Tracks and Reports on QAIT Quality metrics
  
• Works closely with QA Validation to ensure IT systems are validated and maintained in a validated state
  
• Ensures IT Operational Controls are in place and maintained throughout the system lifecycle e.g. Periodic Reviews, Disaster Recovery testing, Performance Monitoring etc
  
• Represents QAIT Quality at NOE/Deviation/Event meetings
  

Requirements

Education and Experience:

• BS/BA in related field and a minimum of 5 years relevant experience preferred; will substitute relevant industry experience for educational requirement.
  
• Strong preference for QA experience within an IT department
  

Knowledge and Skills:

• Knowledge of cGMP, 21 CFR Part 11, Annex 11, GAMP 5
  
• Knowledge and experience of Quality Management Systems
  
• Knowledge and experience of SDLC methodologies in a cGMP regulated environment
  
• Working knowledge of utilizing a risk-based approach to documentation and/or experience with Quality Risk Management is strongly preferred
  
• Excellent technical writing ability and communication skills
  
• Excellent attention to detail, computer skills, and ability to adapt to new systems/technologies
  
• Ability to work independently with only high level guidance and supervision
  

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