QA Specialist (m/f/d)

Your Profile:

• Third Level qualification (Bachelor's degree in Life Sciences or related discipline preferred )
  
• Minimum of 5 years of experience working in a pharmaceutical or biotechnological organization
  
• Minimum of 2 years leader experience working in a cGMP in a regulated environment
  
• Strong knowledge of QA methodologies, tools, and processes.
  
• Experience with quality oversight in manufacturing operations.
  
• Excellent analytical, problem-solving, and decision-making skills.
  
• Strong attention to detail and ability to work in a fast-paced environment.
  
• Experience with regulatory inspections and audits is a plus.
  
• Excellent interpersonal skills
  
• Excellent influencing skills
  
• Excellent presentation skills
  
• Flexible approach - comfortable with on-going change
  
• Takes personable responsibility for their actions
  
• Good communicator who is comfortable to work as part of a team
  
• Focused on achieving results
  
• Self-starter and able to work under minimum supervision
  
• Excellent accuracy
  
• Strong attention to detail
  
• Working knowledge of computer packages

Your Tasks:

• Acts as Quality support for systems/processes providing guidance/feedback on quality issues
  
• QA Specialist to focus on Batch release execution
  
• Assist in achieving timely and compliant final product disposition.
  
• Review, approve, and support procedures and production/testing records as required.
  
• Ensure compliance with aseptic techniques and sterile manufacturing regulations
  
• Perform timely review of documentation / investigations / reports highlighting and assisting in the resolution of concerns commensurate with risk
  
• Collaborate with cross-functional teams to support quality initiatives and continuous improvement efforts.
  
• Work with relevant departments to ensure timely closure of quality actions / findings
  
• Conduct duties in a safe manner and report all safety issues or concerns
  
• Maintain work area to good housekeeping standards
  
• Support team in achieving team goals/targets
  
• Attend team meetings as required
  
• Measure and report RFT / trend data and work with departments to resolve recurring issues
  
• Participate in internal supplier and regulatory audits and key quality initiatives as appropriate
  
• Perform critical/ constructive review of procedures and practices
  
• Support deviation investigations ensuring deviations are closed prior to product release
  
• Ensure compliance to Good Manufacturing Practices (cGMP) at all times

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