QA Systems & Compliance

PSC Biotech Corporation; Cork; On-site; EUR 40,000 - 60,000; Full time

Job summary

PSC Biotech is a leading Biotech Consultancy in Cork, Ireland, seeking a Quality Systems professional to support External Quality within GEO. The role focuses on overseeing Deviations, CAPAs, Change Controls and QMS compliance.

The position is a 12-month contract with responsibilities spanning metric reviews, governance, and cross-functional collaboration across global sites. Ideal candidates have 1+ year biopharma experience in quality/regulatory settings and strong data skills.

Qualifications

• Bachelor’s Degree in science or engineering (required).
• Minimum 1+ years of biopharmaceutical experience in a Quality, Compliance, and/or Regulatory setting.
• Skilled in data analysis and Excel; Power BI and AI tools experience desirable.
• Strong communication and interpersonal skills—oral, written and presentation.
• Works collaboratively with others to meet shared objectives.

Responsibilities

• Perform Quality Systems Metric Review for GEO and oversee metrics and trending to drive on-time closure of Quality records.
• Support development and implementation of digital improvement initiatives for External Quality.
• Manage routine cross-functional meetings to ensure timely closure of Deviations, CAPAs and Change Control, with leadership endorsement.
• Develop/report metrics and standardize them across the Organization.
• Coordinate monthly governance site quality review team (SQRT) meeting for GEO.
• Deliver training on Quality Management Systems within GEO as required.
• Partner with Global Quality Systems Management Team and cross-functional groups to ensure proper application of the QMS.
• Identify and implement continuous improvement initiatives to External Quality systems.
• Participate in change control program for modifications to qualified systems (within GEO).
• Assist in audits and inspections.
• Participate in development and implementation of global alignment projects with sites.
• Support Self Inspection Programme for External Quality.
• Other duties as assigned

Skills

Data analysis

Excel

Power BI

AI tools

Communication skills

Interpersonal skills

Collaboration

Education

Bachelor’s Degree in science or engineering

Tools

Power BI

AI tools

Job description

• Industry Pharma/Biotech/Clinical Research
• Work Experience 1-3 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.

Overview:

This position reports to the Associate Director, ExternalQuality, Quality Systems & Compliance.The main responsibility of this role is supporting the Quality Systemsprogram within External Quality ensuring key Quality System elements such asOversight, Deviations, CAPA’s, and Change Controls are consistentlyadministered and in compliance with relevant Regulatory Standards

This is a 12 Month of contract role

Requirements

Key Responsibilities for this Role as follows;

• Perform the Quality Systems Metric Review for GEO andoversee relevant metrics and trending for each quality system within GEO toproactively drive on-time closure of Quality records.
  
• Support development and implementation of digitalimprovement initiatives for External Quality.
  
• Responsible for managing routine cross-functionalmeetings to ensure timely closure of Deviations, CAPAs and Change Control, withleadership endorsement.
  
• Responsible for development/reporting of metrics andsupporting standardization of these across the Organization.
  
• Co-ordinate monthly governance site quality review team(SQRT) meeting for GEO.
  
• Deliver training on Quality Management Systems withinGEO, as required.
  
• Partner with the Global Quality Systems Management Teamand other cross functional groups to ensure proper application of the QMS.
  
• Identify and implement continuous improvement initiativesto the External Quality systems.
  
• Participate in the change control program formodifications to qualified systems (within GEO).
  
• Assist as needed in audits and inspections.
  
• Participate in development and implementation of globalalignment projects with sites.
  
• Support the Self Inspection Programme for ExternalQuality
  
• Other duties as assigned
  

The ideal candidate will have the following experience/ skills:

• Bachelor’s Degree in science or engineering
  
• Minimum 1+ years of biopharmaceutical experience in aQuality, Compliance, and/or Regulatory setting
  
• Skilled in data analysis and excel. Power bi and AItool’s experience desirable.
  
• Strong communication and interpersonal skills – Oral,written and presentation skills
  
• Works collaboratively with others to meet sharedobjectives.