QC Instrumentation Specialist

The QC Instrumentation Specialist involves supporting the Quality Systems for the QC department, and provides technical support as required by management. The role reports directly to the QC Manager.

Location: Onsite in our Loughrea laboratory (5 days per week)

As QC Instrumentation Specialist you will be responsible for the following:

· Qualification, maintenance, and/or integration of the QC systems, in compliance with up-to-date data integrity, regulatory, and industry standards

· Ensure that the Computer System Validation Procedure is implemented for all computer systems in the QC Laboratory.

· Responsible for change control process and mechanisms required to maintain a state of continued compliance for the QC systems and instrumentation.

· Support the QC department for troubleshooting, investigations, and deviations as an SME.

· Manage deviations, CAPA's and change control's related to the QC and team priorities.

· Serve as an SME for regulatory and internal inspections and audits.

· Maintain and update the Equipment Inventory list for all equipment in the QC Laboratory.

· Liaise with Vendors, Calibration, EHS, QA and QC to deliver instrument qualification and re-qualification schedules.

· Involved in assisting with the service contracts for the calibration of all instrumentation in the QC Laboratory.

· Preparation and review of required validation documentation including protocols and reports.

· Establishment of procedures for management and maintenance of the validated system (data archive, project creation, security etc.).

· Support the QC investigation process by providing accurate and concise information in a timely manner and raising investigations, where required, in QPulse.

· Ensure data integrity requirements are included and met as part of the new instrument qualification.

· Participate in cross functional teams as required to provide support on, and resolution of, QC instrument and equipment validation requirements.

· Partner closely with customers and stakeholders to understand QC instrument and equipment validation requirements and escalate when necessary.

· Proactive engagement with customers and key stakeholders.

· Support the QC laboratories in a state of audit readiness at all times.

· Participate in new initiatives such as the 5S, Standard Work and new projects as they arise.

· Participate in and drive the continuous improvement of all aspects of the QC Lab.

· Ensure compliance with cGMP, corporate standards / Chanelle Quality System, site policies / procedures, and regulatory requirements.

· Technical writing assignments including SOPs, trend reports, risk assessments, laboratory

investigations, and change controls.

· Displays competency in the following technical areas: HPLC, IR, UV, dissolution & physical testing etc.

· Support out of specification, Out of Trend, OOS investigations, Change controls and deviations as required.

· Review calibration and maintenance of laboratory equipment as per calibration procedures.

· Ensure all laboratory logbooks, notebooks & associated documentation are maintained to GLP standard.

· Ensure timely feedback of all queries as appropriate.

· Bring to the notice of the team Manager/supervisor any discrepancies, deviations or non-conformances in testing or work practice.

· Participating in Internal/External Audits and follow-up on Internal / External Audit / Inspection Corrective Actions.

· Ensure existing quality procedures are followed and where appropriate suggestions/change control forms are prepared so that the quality system will be continuously improved.

· Support good housekeeping and hygiene within the laboratory.

· Adherence to laboratory safety measures at all times highlighting areas for improvement

· Ensuring that laboratory is kept tidy and that GLP/GMP standards are adhered to at all times

· Ensure records pertaining to QC are all kept up to date and filed properly.

· Proficiency with Microsoft applications, including Word and Excel and environmental systems

Education & Experience:

· 3rd level qualification – Bachelor’s degree in a science-based discipline.

· Minimum of 5 years in a pharmaceutical’s environment.

· Strong computer skills in MS Office

· Experience working within a pharmaceutical cGLP Environment; with knowledge of EU GMP and US FDA Guideline.

Skills & Competencies:

· Competency in the following areas: URS, IQ, OQ, Equipment Validation, HPLC, IR, UV, dissolution & physical testing, SOPs, Analytical test methods, Change controls, Deviation, CAPA and any other quality records.

· Strong attitude to ALCOA++ requirements

· Ability to build relationships and collaborate with others.

· Good communication skills, both verbal & written.

· Maintains the highest standards of ethical behaviour. Escalates issues appropriately.

· Flexible and shows willingness to learn to develop technical skills.

· Takes a methodical, systematic and structured approach to organising work

· Positive and proactive person who is energized by having great responsibility

· Knowledge and experience of validation or qualification experience with laboratory instrumentation, validation, and project lifecycle, ideally within a pharma environment.

· Experience in updating documentation and reports.

Applicants from diverse backgrounds, including those returning after a career break or with transferable skills from non-traditional career paths, are encouraged to apply. We value varied experiences and are committed to fostering an inclusive environment that supports individuals with disabilities.