QC Instrumentation Specialist

QC Instrumentation Specialist

Chanelle Pharma

Loughrea, Ireland

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:

• 3^rd 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.