Quality Assurance Specialist

PE Global; Carlow; Hybrid; EUR 45,000 - 65,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

PE Global is recruiting a QA Specialist for our client based in Carlow. This 11-month initial contract offers a hybrid working model in a regulated pharmaceutical setting.

The role emphasizes ensuring data integrity, cGMP compliance, and quality system support, including handling deviations, CAPAs, and document management, with cross-functional collaboration across Manufacturing, Engineering, and Quality.

Qualifications

• Bachelor's degree in a related technical discipline.
• Industry qualifications in QMS/Compliance/Auditing desirable.

Responsibilities

• Ensure ALCOA data integrity for records and data in day-to-day activities.
• Complete applicable cGMP training and comply with corporate regulations.
• Drive cGMP/GDP compliance in day-to-day activities.
• Escalate potential cGMP violations and quality concerns.
• Liaise with Quality/QA leads to resolve quality-related queries.
• Provide QA support for new product introductions and releases.
• Ensure processes and procedures for all Quality activities are followed.

Skills

ALCOA data integrity

cGMP training

Quality systems

CAPAs

Change controls

Investigations

Documentation

Cross-functional collaboration

Analytical skills

Regulatory interpretation

Stakeholder management

Education

Bachelor's degree in Science/Engineering/Pharma

Job description

PE Global is currently recruiting a QA Specialist on behalf of our client based in Carlow:

11-month initial contract- hybrid

A contract role for a Specialist, Quality Assurance-

Responsible for activities including some or all of the following and any other tasks as required:

• Ensure data integrity principles: Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) are adhered to for records and data in day-to-day business activities.
• Attend and successfully complete applicable cGMP training. Responds to Operational and business area’s, drives compliance with cGMP and corporate regulations.
• Drives cGMP/GDP compliance in the performance of day-to-day business activities.
• Escalate any potential violation of cGMP and/or other concerns which may affect the safety, efficacy, quality, or purity of MMD human health products and aid resolution.
• Liaise with the Quality/ Business Area Specialists/QP/QA Lead to resolve quality related queries where required.
• Provides expertise & quality support for the introduction of new products onto site in relation to product release where required.
• Ensure and promote that adequate processes and procedures are in place and followed for all Quality activities.
• Report on and assist with monitoring the Quality Management Systems. Generate reports for performance metrics and significant quality events & issues.
• Review and approval of all manufacturing batch/ material documentation including electronic batch records, real time reports, master data using the site systems where required.
• Identify, influence and support compliance initiatives to improve compliance status and overall operational efficiency for batch release at the site.

Requirements

• Bachelor's degree in Science, Engineering, Quality, Biotechnology, Pharmaceutical Sciences, Chemistry, Microbiology, or a related technical discipline.
• Relevant industry qualifications or certifications in Quality Management Systems, Compliance, Auditing, or Operational Excellence are desirable.
• Typically 3 to 5 years' experience in a regulated pharmaceutical, biotechnology, medical device, or healthcare manufacturing environment.
• Demonstrated experience working within Quality Systems and Compliance functions, including management of quality records, deviations, CAPAs, change controls, investigations, Complaints and document management systems.
• Knowledge of current GMP requirements and quality system standards applicable to pharmaceutical manufacturing.
• Experience collaborating with cross-functional teams including Manufacturing, Engineering, Laboratory, Supply Chain, and Technical Operations. Skills and Competencies
• Excellent analytical and problem-solving skills with the ability to evaluate complex quality issues and identify sustainable solutions.
• Strong written and verbal communication skills, including technical writing and report preparation. Ability to manage multiple priorities and deliver results within agreed timelines.
• Effective stakeholder management skills with the ability to influence across functions and levels of the organization.
• Strong attention to detail and a commitment to maintaining data integrity and quality standards.
• Ability to interpret regulatory requirements and translate them into practical site procedures and processes.
• Proficiency in Microsoft Office applications and electronic quality management systems.
• Demonstrated capability to drive continuous improvement and support a culture of quality and compliance.

Preferred Experience

• Experience with site Quality Systems governance, metrics, compliance monitoring, and inspection readiness activities.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***