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QA Validation Senior Specialist

Job description

QA Validation Senior Specialist

Dundalk

 

What you will do in this QA Validation Specialist job:

  • The incumbent provides leadership and oversight of the QA Validation process on site. Responsible for preparing the quality review and ensuring all approvals of qualification/validation documentation and associated data for conformance to regulations, Standard Operating Procedures (SOPs), specifications and other applicable acceptance criteria.
  • Develop, write, review and approve SOPs and controlled documents to support site validation activities and in accordance with client policies.
  • Ensure all equipment and processes are safe, effective and qualified in compliance with industry standards and regulatory expectations.
  • Lead the Validation Review Board (VRB) and provide overall quality leadership and oversight for key functional areas (i.e. PEV, QC, Supply Chain, Engineering, CSV), ensuring that programs, policies and procedures are robust and in keeping with regulatory and client expectations. Lead the team providing clear expectations regarding validation standards.  Report monthly validation KPIs and metrics and ensure opportunities for improvement are identified and actioned accordingly. 
  • As senior specialist, actively participate in the New Product Introduction (NPI) and technology transfer process and ensure all associated protocols are conducted and in place in line with project timelines and impact assessments. Provide support to team members for more complex processes and decisions.  In addition, ensure compliance to regulatory, China and local protocols.
  • Lead by example and ensure associated risk assessments are conducted in line with site expectations and provide a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
  • Lead a team of validation engineer and project engineer and provide support and guidance regarding priorities and objectives. Set goals and objectives as per the associated performance management guidelines and ensure feedback and coaching opportunities are provided timely to employees to ensure optimum performance. 
  • Liaise actively with other functional areas and provide leadership and support to ensure standards are met. Ensure corrective action / preventative action measures are put in place to drive improvement. 
  • Be lead representative for internal and external audits regarding validation processes and protocols. Represent the organisation in more complex risk and impact assessments.
  • Perform all activities in compliance with client safety standards and SOPs
  • Participate in other projects/duties as assigned.

 

 

What you will need in this QA Validation job:

  • Minimum of 10 years’ experience working in a Biologics or similar GMP environment as part of an engineering, technical services or operations function or other combination of experience and educational background that may otherwise satisfy the requirements of the role
  • Previous experience leading an established validation team, working in a green field environment advantageous.
  • Experience working in Quality Assurance role in a GMP Life Science environment.

 

If you are interested in this role apply today and send your CV to Ryant@sigmar.ie

 

 

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