Quality Assurance Specialist Senior

Job Title: Quality Assurance Specialist (Senior)Recruiter- Jessica Amaral

Our client, a multinational bio pharmaceutical company, is seeking a Project/Equipment Engineer to join its expanding team in its Dun Laoghaire site, which includes a bio processing suite and

This role will beresponsible for be a Subject Matter Expert in Technical Support

• Provide overall quality direction and oversight for processes and procedures related to Technology Transfer/NPI, Product Lifecycle changes, Validation and Engineering ensuring that programs, policies and procedures are robust and in keeping with regulatory and clients
  
• Quality review and approval of Technology Transfer, Qualification/Validation documentation and SOPs to support site activities: DS, URS & QRAES documents,Validation Plans, Protocols, IQ, OQ, PQ and associated documents andExecuted validation documents and
  
• Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Qualification/ Validation activities whilst ensuring that all activities meet clients and regulatory
  
• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
  
• Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and
  
• Quality review/approval of BOMs, MBRs and
  
• Write, review and approve Standard Operating Procedures in accordance with clients
  
• Perform all activities in compliance with client safety standards and SOPs
  
• In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role
  

Requirements

• University Science or Engineering related discipline
  
• Relevant experience (7yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for NPI/ technology transfer / product lifecycle
  
• Understanding of principles of Validation and New Product Introduction
  
• Experience in change control, non-conformance, corrective and preventative actions, and validation
  
• Ability to operate across functional boundaries, both internal and
  
• Ability to work independently and remotely with minimum direct
  
• Critical thinking
  
• Strong organisational, communication, coordination, and meeting facilitation
  
• Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and
  
• Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective
  

Benefits

• Benefit from Independent Solution s ethical
  
• 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
  

If you have the above skills & experience, please contactor 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,