QA Specialist – Carlow

Desired Skills: deviations,change control,qa

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