External QA Quality Associate

LSC, Life Science Consultants; Cork; On-site; EUR 47,000 - 71,000; Full time

Job summary

LSC invites applications for an External QA Quality Associate to join a Cork-based biopharmaceutical company manufacturing low-volume bulk API for Phase III trials and long-term market support. The role requires at least 2 years of biopharma QA/Regulatory experience and involves leading QA metrics and digital initiatives.

Key responsibilities include governance of Deviations, CAPAs, Change Controls and cross-functional meetings to ensure timely closure, as well as development of QA metrics and

Qualifications

• Bachelor's Degree in science or engineering.
• Minimum 2+ years of biopharmaceutical QA/Regulatory experience.
• Strong data analysis skills; proficient in Excel; Power BI and AI tools desirable.

Responsibilities

• Perform Quality Systems Metric Review for GEO and oversee metrics and trending to drive on-time closure of Quality records.
• Lead and support development and implementation of digital, AI-enabled and automation initiatives for External Quality.
• Manage routine cross-functional meetings to ensure timely closure of Deviations, CAPAs and Change Control with leadership endorsement.
• Develop and report metrics and standardize these across the Organization.
• Coordinate monthly governance site quality review team (SQRT) meeting for GEO.
• Partner with Global Quality Systems Management Team and cross-functional groups to ensure proper application of the QMS.

Skills

Quality systems

Data analysis

Excel

Power BI

AI tools

Education

Bachelor's Degree in science or engineering

Tools

Power BI

AI tools

Job description

LSC have a great contract opportunity for a External QA Quality Associate to join a Cork based Biopharmaceutical company. The site manufactures low volume bulk API for Phase III clinical trials, initial product launch and long-term market support. The team on site grow, purify, formulate, and bulk fill mammalian cell culture derived APIs for medicines intended for human use.

If you have 2 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!

ABOUT THE PROJECT - KEY RESPONSIBILITIES

• 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.
• Lead and support the development, implementation and continuous improvement of digital, AI-enabled and automation 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-ordinate monthly governance site quality review team (SQRT) meeting for GEO.
• Partner with the Global Quality Systems Management Team and other cross functional groups to ensure proper application of the QMS.

ABOUT YOU - ARE YOUR SKILLS A MATCH?

• Bachelor's Degree in science or engineering.
• Minimum 2+ 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.
• Experience in Quality, Compliance, Regulatory Affairs, Manufacturing Quality or a related function.
• Experience working with Quality Management Systems and regulated processes.
• Experience supporting deviations, CAPAs, change control, inspections, audits or quality governance activities.

Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!