- Our client, a globally renowned pharmaceutical company based in County Dublin have a fantastic opportunity for an experienced QC Laboratory Validation Specialist.
- Working within a dynamic team, the successful candidate will be responsible for the qualification of new instrumentation, modernisation of instrumentation, and facility modification or expansion projects within the QC Laboratories.
- This is an 11 month contract role with strong possibility for extension.
Core Duties and Responsibilities:
- Execute all aspects of QC instrument and equipment validation support throughout the validation lifecycle including:
- New instrument and equipment validation (URS, IQ, OQ, PQ, Traceability Matrices, Summary Reports
- Periodic review of instrument qualification packages as required
- Routine QC support with respect to instrument issues
- Instrument and equipment validation scheduling
- Administration of Laboratory Computerized Systems.
- Liaise with Vendors, Calibration, EHS, QA and QC to deliver instrument qualification and re-qualification schedules.
- Preparation and review of required validation documentation including protocols and reports.
- Ensure data integrity requirements are included and met as part of the new instrument qualification.
- Establishment of procedures for management and maintenance of the validated system (data archive, project creation, security etc.).
- Generation of area and System Administration SOPs.
- Authoring, review and approval of qualification/validation protocols and reports, status reports, regulatory documents and process descriptions.
- Completion of Security reviews, periodic reviews, compendial reviews and APQR sections as they relate to maintaining the qualified status of the system
- Support the QC investigation process by providing accurate and concise information in a timely manner and raising investigations, where required, in QTS.
- 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.
- Maintain the QC laboratories in a state of audit readiness at all times.
- Participate in new initiatives such as the 5S, Standard Work, Data Integrity and IMEX programs as they arise.
- Participate in and drive the continuous improvement of all aspects of the group.
- Ensure compliance with cGMP, corporate standards / Site Quality System, site policies / procedures, and regulatory requirements.
- Technical writing assignments including SOPs, trend reports, risk assessments, laboratory investigations, and change controls.
Minimum Qualifications and Experience:
- Relevant Third level Qualification or equivalent (B.Sc. degree in science, engineering, quality, technical or other related life sciences or engineering discipline.
- 2+ years relevant experience in industry, preferably in a pharmaceutical or relevant GMP manufacturing environment.
- A strong knowledge and experience of validation or qualification experience with laboratory instrumentation, validation and project lifecycle, ideally within a pharma / biopharma FDA regulated environment.
- Excellent communication and interpersonal skills.
- You will be service orientated, delivery focused and can build rapport with key stakeholders both internal and external.
- Proven experience in updating documentation and reports.
- Good working knowledge of IT systems and their interactions with laboratory instrumentation would be considered an advantage but not essential.
- An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
GC North Valley Business Centre, Cork, T23 KC67, Ireland.
+353 21 2066178
Please note, we do not require agency assistance with this role.