Commissioning and Qualification Lead

Job Title:Analyst- Commissioning & Qualification Lead Recruiter-Neha Malik

Duration of Job:12 months Salary- 80-90Euros per hour

Description:

Commissioning and Qualification Lead

Overview:

Commissioning and Qualification (C&Q) lead for a portfolio of Capital Projects in the
Pharmaceutical Lead a team of C&Q engineers to ensure the C&Q activities
associated a portfolio of capital projects are completed safely, as per the schedule, and in
compliance with GMP and Quality

Requirements

• Coordinates and Supervises all C&Q
  
• Approves C&Q planning documents detailing an overall strategy for the
  
• Develops and approve the master list of C&Q test documents and
  
• Reviews and Approves all C&Q summary
  
• Ensures the C&Q schedule is developed and
  
• Ensures all C&Q Engineers who perform C&Q activities have relevant training
  
• Pre Approval and Post approval of C&Q test
  
• Manages Daily C&Q coordination
  
• Responsible for Overall Tracking and Reporting of C&Q status and
  
• Ensures Start-up of equipment/utilities is completed in a safe and coordinated
  
• Assist in the development of User Requirement Specifications (URSs) and Quality
  Risk Assessment for Equipment and Automated Systems (QRAES).

Education / Experience:

• 6+ years experience in Engineering or Commissioning and Qualification
  
• Technical qualification at third level or equivalent in
  
• Extensive knowledge and demonstrated experience managing Commissioning and
  Qualification for Pharmaceutical / Biotechnology
• Experience with sterile / biotech equipment within the pharmaceutical industry is
  
• Knowledge of safety, GMP, and environmental regulatory
  
• Demonstrated strong Communication and Leadership
  
• Demonstrated ability to collaborate with senior stakeholders to achieve optimally
  
• Strong understanding of a risk based approach to commissioning and qualification
  within the biotechnology

Benefits

• Benefit from Independent Solution s ethical principles!
  
• Pre-interview preparation before attending the interview and help to use STAR technology to answer the
  
• 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 Life Science
  
• We offer attractive rates - competitive margins compared to our
  
• Payment on time and in
  
• We are recognized as approved suppliers to leading key pharmaceutical and medical device companies.
  

You must have the right to work in Ireland for this role.

If you have the above skills & experience, please contact or apply at

Independent solutions provide End to End solutions to the life sciences and we are expertise in Bio-Tech, Biopharma, and medical We are the sole source of exceptional Project managers,