Quality Assurance Specialist-Hybrid

PSC Biotech Corporation; Carlow; Ibrido; EUR 65.000 - 95.000; Tempo pieno

Descrizione del lavoro

PSC Biotech Corporation in Ireland seeks a Quality Assurance professional with 3-5 years of experience in pharmaceutical quality roles. You will oversee equipment introduction, validation activities, and quality reviews across engineering and commissioning to support top pharmaceutical client sites.

This role emphasizes regulatory compliance, cGMP/GDP familiarity, and collaboration. You’ll contribute to continuous improvement through Lean Six Sigma, risk assessments, and timely deviation

Competenze

• 3-5 years of experience in a quality role, ideally pharma manufacturing.
• Bachelor’s degree or higher in a related science discipline is preferred.
• Knowledge of regulatory/code requirements related to Irish, European, and International Codes, Standards, and Practices.
• Familiarity with cGMP (current Good Manufacturing Practice) and GDP (Good Distribution Practice) is preferred.
• Strong report, standards, and policy writing skills.
• Experience with equipment and process validation.
• Familiarity with sterile filling processes and equipment.
• Proficiency in Microsoft Office and job-related computer applications.
• Experience or familiarity with Lean Six Sigma methodology is desired.
• Good collaboration skills and the ability to work effectively as part of a team to determine priorities.
• Demonstrated ability to work independently and take ownership of improvement initiatives with a moderate level of guidance.
• Proven ability to drive the completion of tasks.
• Strong decision-making capability with a sense of accountability and responsibility.
• Demonstrated problem-solving skills.

Mansioni

• Provide quality oversight and direction for the introduction of new equipment up to and including validation activities.
• Conduct quality reviews and approvals of engineering/commissioning and qualification activities.
• Conduct quality reviews and approvals of validation/automation/utilities activities.
• Support deviation Investigations and close out in a timely manner.
• Quality oversite of Change controls related to introduction, commissioning and qualification of new equipment.
• Quality oversite of Quality Risk assessments related to introduction, commissioning and qualification of new equipment.
• Facilitate compliance direction for the site by adhering to divisional policies, guidelines, and regulatory requirements. Proactively evaluate site compliance against emerging trends and initiate major compliance initiatives for improved status and operational efficiency. Actively participate in Plant/Quality committees and collaborate with other site functional groups.

Conoscenze

Quality oversight

Validation activities

Regulatory understanding

cGMP/GDP knowledge

Lean Six Sigma

Collaboration

Independent ownership

Decision making

Problem solving

Formazione

Bachelor's degree or higher in related science

Descrizione del lavoro

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• City Carlow
• State/Province Carlow
• 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 unit

Role Functions:

• Provide quality oversight and direction for theintroduction of new equipment up to and including validation activities.
  
• Conduct quality reviews and approvals of engineering/commissioning and qualification activities.
  
• Conduct quality reviews and approvals ofvalidation/automation/utilities activities.
  
• Support deviation Investigations and close out in atimely manner.
  
• Quality oversite of Change controls related tointroduction, commissioning and qualification of new equipment.
  
• Quality oversite of Quality Risk assessments related tointroduction, commissioning and qualification of new equipment.
  
• Facilitate compliance direction for the site by adheringto divisional policies, guidelines, and regulatory requirements. Proactivelyevaluate site compliance against emerging trends and initiate major complianceinitiatives for improved status and operational efficiency. Activelyparticipate in Plant/Quality committees and collaborate with other sitefunctional groups.
  

Requirements

Experience, Knowledge & Skills:

• A minimum of 3-5 years of experience in a quality role,ideally in a pharmaceutical manufacturing environment.
  
• A bachelor’s degree or higher in a related Sciencediscipline is preferred.
  
• A minimum of 3 years of experience in a quality role,ideally in a pharmaceutical manufacturing environment.
  
• Knowledge of regulatory/code requirements related toIrish, European, and International Codes, Standards, and Practices.
  
• Familiarity with cGMP (current Good ManufacturingPractice) and GDP (Good Distribution Practice) is preferred.
  
• Strong report, standards, and policy writing skills.
  
• Experience with equipment and process validation.
  
• Familiarity with sterile filling processes and equipment.
  
• Proficiency in Microsoft Office and job-related computerapplications.
  
• Experience or familiarity with Lean Six Sigma methodologyis desired.
  
• Good collaboration skills and the ability to workeffectively as part of a team to determine priorities.
  
• Demonstrated ability to work independently and takeownership of improvement initiatives with a moderate level of guidance.
  
• Proven ability to drive the completion of tasks.
  
• Strong decision-making capability with a sense ofaccountability and responsibility.
  
• Demonstrated problem-solving skills.
  

Qualifications & Education:

• A Bachelor's degree or higher in a related Sciencediscipline is preferred.