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Contact Info
Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Manufacturing Process Specialist (BU3 - Purification)


Reference:RK2174 Location: Cork
Qualification:DegreeExperience:1-2 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Manufacturing Coordinator

Manufacturing Process Specialist (BU3 - Purification)
RK2174
Contract - 12 months
Cork


We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


Duties:

• Carry out all activities in compliance with corporate and cGMP/EHS regulatory requirements.
• Compliance with Manufacturing and general site procedures at all times.
• Completion of all documentation in compliance with site procedures and GDP.
• Lead, support and participate in commissioning and qualification activities both current and future projects (and annual re-qualification activities). Also support to validation activities.
• Prioritize and schedule activities to support business needs and to meet requirements of Master Production Schedule.
• Lead and Support investigation and resolution of problems on plant.
• Generate and assist with generation, review and revision of Manufacturing documentation as necessary.
• Ensure that personal training requirements are completed in compliance with site procedures. Training and support for new recruits to the Manufacturing group
• Support ongoing studies by Validation, OTS and other support functions.
Monitoring and troubleshooting of the commercial and clinical manufacturing processes and process optimization
• Monitoring and reporting of process performance using statistical process control
• Generation of data and reports to support Annual Product Reviews and Regulatory submissions
• Troubleshooting of DCS (e.g Delta V) and PLC control systems
• Investigating and resolving Deviations raised within the Manufacturing Department
• Participate in/ Lead Cross Functional teams when required
• Support of Commissioning and Qualification activities
• Preparation and updating of Batch Records, Procedures and Work Instructions
• Provide process and equipment related training as required within the Manufacturing Department


Experience and Education:

  • Relevant third level qualification in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science or Engineering
  • 2 years industry experience - Bio-pharmaceutical Manufacturing preferred
  • Experience executing GMP change controls and investigating quality issues


If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or [email protected] for further information.