Upstream Compliance Coordinator

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

Overview:

A fantastic and exciting opportunity has arisen for an Upstream Operations Support Specialist. The role will provide key operational support to the Upstream shift teams to ensure right first-time execution/delivery of manufacturing of batches. The Upstream Operations Support Specialist will support routine operations in the areas of safety and GMP compliance and will report to Upstream Operations Support Lead.

This position will play a pivotal and critical role in the manufacture of biologics-based medicines including immuno-oncology.

Requirements

Role Functions:

• As an Operations Specialist you will work with the Integrated Process Team (IPT) to ensure the effective and efficient on-time delivery of batch production in Upstream Operations. This requires the delivery of process excellence and reliability across all areas of the IPT.
  
• Support Shift Operations team to consistently deliver on specific area Key Performance Indicators (KPIs) e.g. EHS metrics Production Plan OEE compliance and team training including coordination of daily production activities.
  
• Manage & track creation & updates to Standard operating Procedures (SOPs) Work Instructions (WIs) for New Product Introduction
  
• Ownership of CAPAs
  
• Support compliant operations through management of materials used in Upstream Operations.
  
• Data analysis supporting operations in safety quality delivery and cost
  
• Link to finance department for monthly materials reporting and approvals
  
• Liaise with stakeholders including Shift Operations Tech Ops Quality Assurance
  
• Collate and analyse downtime tracking data and link to problem solving.
  
• Provide Communication updates to manufacturing shift teams.
  
• Co-ordinate and support Audits including preparatory work.
  
• Coordinating and authoring Quality Notifications and Corrective and Preventive Actions (CAPAs). Ensuring accurate and timely documentation and updates to maintain compliance with quality standards and regulations.
  
• Co-ordination of Contractors and Visitors to BDS.
  

Required Skills:

• Working knowledge of SAP
  
• Experience with Qualified Document Management systems
  
• Self-motivated with excellent organizational skills
  
• Ability to interact with multiple stakeholders across numerous departments.
  
• Ability to work independently and as part of a team.
  
• Advanced soft skills e.g. MS Word Excel PowerPoint to generate metrics presentations as applicable
  
• Excellent communication skills
  

Desirable Skills:

• Working knowledge of Upstream processes is highly desirable.
  
• Knowledge of Lean Six Sigma and Lean methodologies with an understanding of regulatory requirements.
  

Education:

• Degree or 3rd level qualification (Science Engineering).