Cpl in partnership with our client Pfizer are seeking a QC Equipment Validation specialist to join the team for an 11 month fixed term contract in their state of the art Dublin, Grange Castle Site.
Job Purpose:
This position is to provide support to Quality Control with instrument and equipment, Data Integrity, validation, and system administration.
This job description is designed as a combined list of the general tasks expected of a QC Specialist – QC Equipment Validation. Personnel may be asked to perform some, or all of the tasks listed as required by the functional area. The contents of this document are not intended to be exhaustive and additional duties may be directed by the Team Lead and / or Manager.
Job Responsibilities:
• Execute all aspects of QC instrument and equipment validation support:
• 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
• 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 qualification of new instrumentation.
• 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 and eQMS.
• 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 / Pfizer Quality System (PQS), site policies / procedures, and regulatory requirements.
• Technical writing assignments such as SOPs, trend reports, risk assessments, laboratory investigations, and change controls.
Education / Experience:
• You will be service orientated; delivery focused and can build rapport with key stakeholders both internal and external.
• 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.
• 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.
This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities required of the incumbent. Incumbents may be asked to perform other duties as required.