Quality Systems Compliance Specialist

About PSC Biotech

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 points 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 to 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 through Learning & Development in-house training mentorship with 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:

The Quality Systems Compliance Specialist is responsible for maintaining and continuous improvement of our Quality Management System throughout their knowledge and areas of expertise. Ensure that objectives are effectively achieved, consistent with our requirements to ensure compliance, safety, and reliable supply to our customers.

Responsibilities:

• Provide quality support to the project and site, including training and guidance on the interpretation and implementation of our Guidelines / Policies and regulatory requirements.
  
• The main areas of expertise are, but not limited to, specific tasks and roles such as: deviation management, change control management, quality systems management, document/SOP management, data integrity management, GMP training & knowledge management.
  
• Ensure the health & well-being of the Quality Management system at the site to ensure timely actions are taken to meet compliance & production needs.
  
• Serve as support for metrics management for site deviation management and change control systems.
  
• Support the review and approval of site deviation and investigation reports.
  
• Support maintenance of the site master file and site manufacturing license and variations, as required.
  
• Ensure root causes have been identified and corrective action implemented and demonstrate basic knowledge of six sigma, LEAN, and root cause analysis tools used for identifying and correcting deviations.
  
• Day-to-day management of Deviation, CAPA, and Change Control, QRM metrics.
  
• Support the oversight of the quarterly deviation trending process (by cross-functional area owners) on a routine basis and responsible for the completion of annual trending at Site.
  
• Liaise directly with cross-functional departments to ensure that change control and deviation management system requirements are met.
  
• Support Regulatory and Compliance Inspections at the site, as required.
  
• Support for management of recalls, as required.
  
• Comply with our Global and regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
  
• Build a Quality culture that delivers unconstrained supply, Right First Time to our patients.
  
• Support Quality Risk Management process.
  

Skills Required:

• Over 4 years' experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations or Technical Operations.
  
• Motivated to be an inspiring member of a high-performing team.
  
• Excellent interpersonal skills: communication, decision making, people influencing skills.
  
• Ability to interact with multiple stakeholders.
  
• Desire to continuously learn, improve and develop.
  
• Excellent knowledge of relevant Quality and Compliance Guidelines (cGMP, Auditing, Quality Management Systems, Quality Agreements, Regulatory Affairs, Training) and respective regulations.
  
• Experience with new product introductions and/or process qualification/technology transfer.
  
• Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering, or equivalent.