Quality Assurance Specialist

Headcount Solutions Polska Sp. z o.o.; Carlow; Hybride; EUR 55 000 - 75 000; Plein temps

Résumé du poste

Headcount Solutions Polska Sp. z o.o. invites applications for a Quality Assurance Specialist to join a leading pharmaceutical multinational. This is a hybrid role with 2–3 days on site in Ireland and close collaboration with a global QA team.

You will support new product introductions, review batch records, ensure ALCOA data integrity, and drive cGMP/GDP compliance in daily activities, coordinating with Manufacturing, Engineering and Quality to ensure timely batch releases.

Qualifications

• Bachelor's degree in Science, Engineering or related technical discipline.
• Experience with Quality Management Systems and regulatory compliance.
• 3–5 years' experience in a regulated pharmaceutical/biotech environment.

Responsabilités

• Provide quality support for new product introductions and product release.
• Review and approve manufacturing batch/material documentation including electronic batch records and master data.
• Ensure processes and procedures are in place and followed for all quality activities.
• Report on and monitor the Quality Management System and generate performance reports.
• Collaborate with QA lead/QP to resolve quality queries.
• Ensure ALCOA data integrity for records and data.
• Drive cGMP/GDP compliance in day-to-day activities.
• Identify and support initiatives to improve compliance and batch release efficiency.

Connaissances

GMP knowledge

QMS experience

ALCOA data integrity

Cross-functional collaboration

Formation

Bachelor's degree in Science/Engineering or related discipline

Description du poste

Quality Assurance Specialist - Hybrid

An Opportunity has arisen for a Quality Assurance Specialist to become a key member of the Quality Team within a Leading Pharmaceutical Multinational.This is a hybrid role with a minimum of 2-3 days on site.

Key Responsibilities:

• Provides expertise & quality support for the introduction of new products onto site in relation to product release where required
• Review and approval of all manufacturing batch/ material documentation including electronic batch records, real time reports, master data using the site systems 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.
• Liaise with the Quality/ Business Area Specialists/QP/QA Lead to resolve quality related queries where 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.
• Drives cGMP/GDP compliance in the performance of day-to-day business activities.
• Identify, influence and support compliance initiatives to improve compliance status and overall operational efficiency for batch release at the site.

Education and Experience

• Bachelor's degree in Science, Engineering 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.
• Strong written and verbal communication skills, including technical writing and report preparation.
• 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.