Quality Assurance Specialist

Headcount Solutions Polska Sp. z o.o.; Carlow; Hybrid; EUR 45,000 - 75,000; Full time

Job summary

Headcount Solutions Polska Sp. z o.o. seeks a Quality Assurance Specialist to join a leading pharmaceutical multinational. This hybrid role requires 2–3 days on site in Ireland, Leinster, Carlow.

You will support product releases, review batch records, maintain QMS, and ensure data integrity while driving GMP compliance across cross-functional teams.

Qualifications

• Bachelor's degree in Science, Engineering or related technical discipline.
• Typically 3 to 5 years' experience in a regulated pharmaceutical/biotech/manufacturing environment.
• Experience with Quality Systems, Deviations, CAPAs, Change Controls, Investigations and document management.
• Knowledge of current GMP requirements and quality system standards for pharma manufacturing.
• Strong attention to detail and commitment to data integrity.

Responsibilities

• Provides expertise and quality support for introducing new products onto site for release.
• Review and approve manufacturing batch/material documentation and electronic records.
• Ensure processes and procedures are in place and followed for all Quality activities.
• Report on Quality Management Systems and generate performance reports.
• Liaise with Quality/Business Area Specialists and QA Lead to resolve queries.
• Ensure ALCOA principles are applied to records and data in day-to-day work.
• Drive cGMP/GDP compliance in daily activities.
• Identify and support initiatives to improve compliance and batch release efficiency.

Skills

GMP knowledge

Documentation

Data integrity (ALCOA)

Cross-functional collaboration

Technical writing

Quality metrics

Education

Bachelor's degree in Science/Engineering or related

Tools

Electronic batch records

Job description

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.