QC Equipment Specialist

• Execute all aspects of QC instrument and equipment validation support throughout the validation lifecycle:

• 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.
• 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 programs as they arise.
• Participate in and drive the continuous improvement of all aspects of the group.
• Ensure compliance with cGMP, corporate standards, site policies / procedures, and regulatory requirements.
• Technical writing assignments including SOPs, trend reports, risk assessments, laboratory investigations, and change controls.

• 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.
• 5+ 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.

Morgan McKinley