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.