QA Systems & Compliance

PSC Biotech® Corporation; Cork; On-site; EUR 45,000 - 60,000; Full time

Job summary

PSC Biotech Corporation in Ireland is seeking a Quality Systems professional to support External Quality initiatives within GEO, focusing on deviations, CAPAs and change controls in line with regulatory standards.

The 12-month contract role reports to the Associate Director, External Quality, Quality Systems & Compliance, and involves cross-functional collaboration, data analysis, and delivering training and metrics to improve global quality systems.

Qualifications

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

Responsibilities

• Perform the Quality Systems Metric Review for GEO and oversee metrics to drive timely 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 these across the Organization.
• Coordinate monthly governance site quality review team (SQRT) meetings for GEO.
• Deliver training on Quality Management Systems within GEO.
• Partner with Global Quality Systems Management Team and cross functional groups to apply the QMS.
• Identify and implement continuous improvement initiatives to External Quality systems.
• Participate in the change control program for modifications to qualified systems.
• Assist in audits and inspections.
• Participate in development and implementation of global alignment projects with sites.
• Support the Self Inspection Programme for External Quality.

Skills

Data analysis

Excel

Power BI

AI tools experience

Communication skills

Collaboration

Education

Bachelor’s Degree in science or engineering

Job description

Who are we?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

About PSC Biotech

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Overview:

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

This is a 12 Month of contract role

Key Responsibilities for this Role as follows;

• Perform the Quality Systems Metric Review for GEO and oversee relevant metrics and trending for each quality system within GEO to proactively drive on-time closure of Quality records.
• Support development and implementation of digital improvement initiatives for External Quality.
• Responsible for managing routine cross-functional meetings to ensure timely closure of Deviations, CAPAs and Change Control, with leadership endorsement.
• Responsible for development/reporting of metrics and supporting standardization of these across the Organization.
• Co-coordinate monthly governance site quality review team (SQRT) meeting for GEO.
• Deliver training on Quality Management Systems within GEO, as required.
• Partner with the Global Quality Systems Management Team and other cross functional groups to ensure proper application of the QMS.
• Identify and implement continuous improvement initiatives to the External Quality systems.
• Participate in the change control program for modifications to qualified systems (within GEO).
• Assist as needed in audits and inspections.
• Participate in development and implementation of global alignment projects with sites.
• Support the Self Inspection Programme for External Quality
• 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 a Quality, Compliance, and/or Regulatory setting
• Skilled in data analysis and excel. Power bi and AI tool’s experience desirable.
• Strong communication and interpersonal skills – Oral, written and presentation skills
• Works collaboratively with others to meet shared objectives.