Quality Assurance Specialist

PE Global; Carlow; Híbrido; EUR 52.000 - 65.000; Jornada completa

Descripción de la vacante

PE Global is currently recruiting a QA Specialist for our client in Carlow. This 11-month initial contract offers hybrid work with 2–3 days on site. The role focuses on quality assurance activities, data integrity (ALCOA), and cGMP compliance across QA systems.

Ideal candidates have 3–5 years in a regulated pharma/manufacturing environment and a related Bachelor’s degree. Please note visa sponsorship is not available for this position.

Formación

• 3–5 years in a regulated pharmaceutical/biotech/medical device environment.
• Experience with Quality Systems and Compliance functions incl. deviations, CAPAs, change controls, investigations, complaints.
• Knowledge of GMP requirements and quality system standards.
• Experience collaborating with cross-functional teams (Manufacturing, Engineering, Lab, Supply Chain).

Responsabilidades

• Ensure data integrity and ALCOA principles in day-to-day activities.
• Participate in cGMP training and ensure compliance with corporate regulations.
• Drive cGMP/GDP compliance in daily activities and escalate potential violations.
• Liaise with QA Leads/QP to resolve quality-related queries.
• Provide QA support for new products and site release activities.
• Develop and monitor quality processes and generate performance reports.
• Review manufacturing batch/material documentation and electronic batch records.
• Support site quality initiatives to improve compliance and efficiency.

Conocimientos

Quality Management Systems

GMP compliance

Analytical problem-solving

Written and verbal communication

Multitasking

Stakeholder management

Attention to detail

Regulatory interpretation

Continuous improvement

Data integrity (ALCOA)

Educación

Bachelor's degree in Science/Engineering/Quality/Pharmaceuticals

Herramientas

Microsoft Office

Electronic Quality Management System

Descripción del empleo

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-

• Role will be hybrid 2-3 days on site minimum
• There is no shift work its a days role.
• Preferred experience in Quality Assurance role,
• Familiar with Quality Management Systems e.g. Deviations, Complaints, Annual product reviews, change control, Batch record review

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 human health products and aids 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.

Education

• 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.

Experience

• 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

• Strong understanding of Quality Management Systems and GMP compliance requirements.
• 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***