Quality Assurance Specialist

z o.o. in Carlow Ireland. 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. #J-18808-Ljbffr. Compensation: 55.000000 - 75.000000.