QC Laboratory Equipment Validation Specialist (11 month contract)
Full Time
Dublin, County Dublin
Posted
Job description
CPL 11 month Contract
QC Laboratory Equipment Validation Specialist working within a dynamic team responsible for the qualification of new instrumentation, modernisation of instrumentation, and facility modification or expansion projects within the QC Laboratories.
Responsibilities will include:
- 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, 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 / Pfizer Quality System (PQS), site policies / procedures, and regulatory requirements.
- Technical writing assignments including SOPs, trend reports, risk assessments, laboratory investigations, and change controls.
About You:
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You will be service orientated; delivery focused and can build rapport with key stakeholders both internal and external.
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Relevant Third level Qualification or equivalent (B.Sc. degree in science, engineering, quality, technical or other related life sciences or engineering discipline.
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1+ years relevant experience in industry, preferably in a pharmaceutical or relevant GMP manufacturing environment.
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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.
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Excellent communication and interpersonal skills.
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Proven experience in updating documentation and reports.
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Good working knowledge of IT systems and their interactions with laboratory instrumentation would be considered an advantage but not essential.
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An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
Additional Information
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In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland.
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Please note there is no relocation support available for this position
How to apply
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Make a difference today, all suitable candidates should apply with CV below. We are looking forward to hearing from you!
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
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