Validation Compliance Specialist

Orion Group Life Sciences are currently recruiting a Validation Compliance Specialist on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 11-month contract with potential to extend.
 
Hybrid Role
 
Role
Our Carlow site are excited to offer a fantastic Compliance Specialist (Validation) for candidates interested in a new challenge in a cGMP regulatory environment. The successful candidate will provide compliance support to all areas of Validation, ensuring compliance to cGMP & regulatory requirements.
 
Bring energy, knowledge, innovation to carry out the following:

• Provide compliance support for validation activities on site.
• Support Regulatory, Divisional and Internal audits on site.
• Respond to operational and business areas, ensuring compliance with cGMP & regulatory requirements
• Accountable for compliance via documentation completion, risk assessments, closing out corrective actions and proactively highlighting any issues around compliance 
• Responsible for maintaining site Validation Master Plan
• Generation & approval of periodic revalidation plan & report
• Generation & approval of periodic review plan
• Generation & approval of validation governance report
• Generation & coordination of Annual Product Review validation chapters
• Inspection readiness coordination & support including oversight of story board preparation and ensuring GMP compliant documents are available.
• Review of validation documentation.
• Investigation & RCA support.
• Ensure compliance with the QMS, industry/company specific standards and regulations. 
• Demonstrate effective communication and interpersonal skills. 
• Proactively & consistently improve personal knowledge and capability.  
• Demonstrate an awareness of own capabilities and development needs.  
• Support continuous improvement by active participation in, and contribution to, projects and problem-solving including use of MPS processes and tools. 
• Participate in driving a high performing & inclusive culture, stimulating personal growth & development.   
• Work collaboratively to drive a safe and compliant culture in Carlow.
• May be required to perform other duties as assigned

  
What skills you will need:
In order to excel in this role, you will more than likely have considerable experience in a comparable role, with experience operating as individual contributor adding value to the business in a GMP manufacturing setting, as well as the following qualifications/skills:

• Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.
• Exception / Deviation Management and Change Control.
• Equipment Periodic Validation
• Equipment Validation Lifecycle
• Project Management Skills/Qualification
• Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable
• Evidence of continuous professional development is desirable.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Ability to analyse and interpret complex data, and link to equipment performance and out of specification findings as appropriate.
• Report, standards, policy writing skills required.
• Equipment and process validation.
• Sterile Fill-Finish processes and equipment.
• Proficiency in Microsoft Office and job-related computer applications required
• Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.

  
Knowledge and experience of the below areas will be considered advantageous
 

• Autoclave/SIP Sterilisation Validation
• Dry Heat Sterilisation
• Isolator VHP/HVAC Qualification
• Controlled Temperature Units/Equipment Qualification
• Validation of Tank CIP & Parts Washers for in-process components.
• Cleaning recovery studies using TOC and swab methods.
• CCI qualification.
• Shipping Qualification.
• Filter Validation.
• Vial and Syringe Processing Technologies

  
The successful candidate will be required to work both independently and in a cross functional team to accomplish validation compliance objectives. Works with moderate work direction and is skilled and knowledgeable to the position.
  
 

  
 


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