Job description
Job Title: QC Lead Investigator
Job Purpose:
To lead QC deviations (ERs, QARs) and laboratory investigations (LIRs, RAACs) as area SME, including authoring investigation reports and supporting assessments to ensure on time closure and batch disposition.
Job Responsibilities:
- To lead / provide SME input into deviations (ERs, QARs) and laboratory investigations (LIRs, RAACs). This includes authoring investigation reports and supporting assessments as needed to ensure compliance with procedures.
- Drive the identification and implementation of effective CAPAs to support reduction in deviations.
- Responsible for on time closure of records and meeting all record milestones.
- Support Key Meetings in QC, e.g., Investigations/ LIR Meetings, change control meetings, other as required.
- Responsible for performing Pfizer Human Performance interviews and Method 1 ‘s arising from investigations.
- Work to implement a culture of Right First Time in QC and to provide leadership in the use of OE principles to optimize technical and business processes.
- Perform and assist in additional duties as directed by the Quality Control Manager.
Education/Experience
To be successful in this role the following are prerequisites to application:
- Third level Qualification in Science, Engineering or equivalent is preferred, though not essential. Exceptions may be considered where relevant skills/experience and correct attitude and behaviours exist (this may be supplemented by further education in parallel).
- Previous relevant Quality experience as detailed above in the job responsibilities section, within a QA/QC GMP environment in a Pharma/Biotech company.
- Excellent communication and interpersonal skills.
- An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
We will only accept applications from colleagues via the formal route within Workday. Please do not submit paper or e-mail applications.
In line with good development planning, colleagues should discuss their suitability and/or readiness for a vacancy with their line manager prior to application. Colleagues are required to inform their manager if they are invited to attend interview. Where a line manager is not able to support an application either for suitability, readiness or business reasons, and a colleague continues to make an application, it is possible that an offer may not be made or may be withdrawn.
Applications not received by the closing date will only be accepted in exceptional circumstances and will require the support of your senior management team.
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.
Quality Assurance and Control
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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