QC Instrumentation Specialist at Chanelle Pharma
Location: Onsite in our Loughrea laboratory (5 days per week)
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.
Responsibilities
* 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 and change control related to 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
* Assist 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
* Establish 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 to elevate issues when necessary
* Engage proactively with customers and key stakeholders
* Support the QC laboratories in a state of audit readiness at all times
* Participate in new initiatives such as 5S, Standard Work and new projects as they arise
* Drive 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
Technical Competencies
* 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 and associated documentation are maintained to GLP standard
* Ensure timely feedback of all queries as appropriate
* Identify discrepancies, deviations or non‑conformances in testing or work practice and bring to the notice of the team manager/supervisor
* Participate in internal/external audits and follow up on corrective actions
* Support quality procedures and prepare or modify change control forms to continuously improve the quality system
* Support good housekeeping and hygiene within the laboratory
* Follow laboratory safety measures at all times and highlight areas for improvement
* Keep laboratory tidy and maintain GLP/GMP standards at all times
* Keep records pertaining to QC up to date and filed properly
* Proficiency with Microsoft applications, including Word and Excel and laboratory systems
Education Experience
* 3rd level qualification – Bachelor’s degree in a science‑based discipline
* Minimum of 5 years in a pharmaceutical environment
* Strong computer skills in MS Office
* Experience working within a pharmaceutical cGLP environment; knowledge of EU GMP and US FDA guideline
Skills Competencies
* Competency in 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 and 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.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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