Plant Quality Assurance (PQA) Snr Associate

• Perform all activities in compliance with company safety standards and standard operating procedures.
  
• Observe and provide real-time quality oversight and support for manufacturing on the floor.
  
• Perform purposeful presence on the floor audits.
  
• Perform manual visual inspection AQL audits of vials and syringes.
  
• Perform QA reserve sample inspections as part of the annual reserve inspection program and in support of customer complaint investigations
  
• Certification of defect panels.
  
• Provide quality support for triage and investigation of all classes of deviation events.
  
• Review/approve deviations for closure ensuring compliance with appropriate standards.
  
• Review/approve production batch records, and associated documentation in preparation for qualified person disposition activities.
  
• Provides training and advice to staff in order for them to perform their desired functions.
  
• Write, review and approve standard operating procedures in accordance with company policies.
  
• Support continuous improvement and operational excellence initiatives
  
• Any other tasks/projects assigned as per manager s request.
  

Requirements

• University degree. Engineering or Science related discipline preferred.
  
• Relevant experience (4 yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
  
  
  

• Excellent written and verbal communication skills.
  
• Experience working with dynamic cross-functional teams and proven abilities in decision making.
  
• Strong organizational skills, including ability to follow assignments through to completion.
  
• Demonstrated ability in problem solving and experience in managing Root Cause Analysis /Deviation investigations.
  
• Experience working in aseptic operations, protein formulation, vial and syringe filling.
  
• Knowledge ofapplicable Regulatory requirements, and ability to evaluate compliance issues.
  

Benefits

• Benefit from Independent Solutions ethical principles!
  

• We look after our team, we know the business, we have been working in the sector >20 years. We are not a recruitment agency
  

• While placed on client sites you will be an integral part of our team, gaining support and access to the knowledge and experience of our cross functional LifeScience team
  

• We offer attractive rates - competitive margins compared to our competitors
  

• Payment on time and in full
  

• We continue to partner and grow our client base and thereby ensure that we have a continuous supply of High-Value Projects
  

• We work for you!