QA Systems & Compliance Technical Manager

QA Systems & Compliance Technical Manager

• Industry Pharma/Biotech/Clinical Research
• Work Experience 5+ years
• City Cork
• State/Province Cork
• Country Ireland

Job Description

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.

'Take your Career to a new Level'

PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.

Employee Value Proposition

Employees are the "heartbeat" of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient's expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.

Requirements

Essential Job Functions:

• Act as a business process manager for applicable qualitysystems.
  
• Assess GMP and regulatory compliance risk areas anddevelop and implement risk mitigation measures in conjunction with theaccountable parties.
  
• Work with key stakeholders to identify and implementsystem improvements,
  
• Analyse performance through metrics and trending,
  
• Troubleshoot issues and support the business withqueries,
  
• Benchmark leading practices & identify opportunitiesto enhance systems,
  
• Liaise with global colleagues to share learnings toensure consistency across the network and alignment with global processes.
  
• Provide QA review and/or approval for Supplier Managementand other Quality System activities impacting GxP operations, including (butnot limited to):
  
• Deviations
  
• Changes
  
• Specifications
  
• Technical / Quality Agreements
  
• Provide additional support to Quality Systems andCompliance team:
  
• Support audit and inspection activities for site,including preparation, participation, and follow up actions.
  
• Lead activities associated with the site qualitymanagement review process.
  
• Other duties as assigned.
  

Qualifications & Experience:

Education:

• Bachelor's degree in Pharmaceutical Sciences, ProcessEngineering or related discipline.
  

Experience:

• 10-15+ years experience within GMP-regulatedpharmaceutical or biotechnology environments
  
• 3-5 years in leadership roles, with experience in peoplemanagement and a proven ability to influence cross-functional teams andstakeholders.
  
• Knowledge of EU GDP Guidelines and regional regulatoryrequirements.
  
• Proven ability to lead change initiatives and driveimprovements within and across functions which enable compliance and mitigaterisk
  
• VIVA Vault - QMS
  

Skills:

• Excellent communication and influencing skills across allorganizational levels.