Quality Assurance Specialist-Hybrid

PSC Biotech Ltd; Carlow; On-site; EUR 60,000 - 85,000; Full time

Job summary

PSC Biotech Corporation in Ireland seeks a QA professional to drive quality oversight for new equipment, validation, deviation investigations, and change controls in a pharma manufacturing setting.

The role requires 3–5 years in quality, a science degree, and strong regulatory knowledge. Collaboration with cross-functional teams and adherence to cGMP/GDP are essential.

Qualifications

• Bachelor’s degree or higher in a science discipline is preferred.
• 3-5 years of quality role experience in pharma manufacturing.
• Knowledge of Irish, European and international codes and standards.
• Familiarity with cGMP and GDP principles.
• Strong report, standards and policy writing skills.
• Experience with equipment and process validation.

Responsibilities

• Provide quality oversight for new equipment introduction, validation activities.
• Conduct quality reviews and approvals of engineering/commissioning and qualification activities.
• Support deviation investigations and closure in a timely manner.
• Oversee change controls related to equipment introduction, commissioning and qualification.
• Ensure site compliance with divisional policies and regulatory requirements.
• Participate in Plant/Quality committees and collaborate with teams.

Skills

Quality oversight

Regulatory knowledge

Lean Six Sigma

Problem-solving

Team collaboration

Independent working

Education

Bachelor’s degree in science

Tools

Microsoft Office

Job description

• 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.