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Medical Quality Governance Associate
3 months ago
Job Description - Medical Quality Governance Associate
The Medical Quality Governance Associate role supports the Pfizer UK Quality Management System (QMS), driving compliance and inspection and audit readiness with specific accountability as the specialist in the coordination of procedural document approval and training assignments in key Pfizer systems.
The MQG Associate scope spans the local areas that are defined by the Medical Quality Management System (QMS), where these impact in-country Medical operations. This may include lines beyond Medical, e.g., Commercial, where these are involved in regulated activities governed by the Medical QMS.
Business Units:
Internal Medicine & Hospital, Vaccines & Antivirals, Inflammation & Immunology, Rare Disease, Oncology
INTERACTIONS / ORGANIZATIONAL RELATIONSHIPS
- The MQG Associate reports solid line into the Director of UK Medical Quality Governance and works under the technical supervision of a team of Medical Quality Governance Managers and Officers.
MAIN REPONSIBILITIES / DUTIES
Procedures
- Manages the approval of process documentation utilising various global and local electronic systems
- Ensures UK data in global systems is correct
- Maintains internal tracking logs of documentation
- Act as a local Subject Matter Expert providing support to the MQG Team for all aspects of document management
Medical-compliance related training
- Manages the assignment of training to UK individuals using the global electronic training system
- Act as a local Subject Matter Expert on local training management and Pfizer’s Global Learning Management System
- Supports training completion compliance
- Maintains internal tracking logs for training assignments
Project Management
- Participate in, and sometimes lead, ad hoc projects initiated by the MQG Team, to assist the effectiveness of the team, utilising specialist knowledge of global and local electronic systems and processes
PCO-Specific Responsibilities
- Assist the business in reviewing and ensuring availability of records prior to inspections and audits.
REQUIRED SKILLS
Education & Experience
- Knowledge and understanding of document management in a regulated environment
- Knowledge and understanding of Quality systems, processes, audits and inspections
- Excellent organisational and communication skills
- Ability to work to tight timescales and prioritise own work
Desired technical and behavioural skills:
- Previous experience of overseeing document management and training processes
The core digital capabilities identified are as follows:
- Capability to use digital technology provided by the organisation
- Confident and competent with digital compliance requirements
- Experience in using a range of digital platforms
- Basic understanding of core digital metrics used by the organization
- Awareness and integration of digital channels to meet our customer needs
- N.B digital technology refers to _
Work Location Assignment: On Premise
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.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation
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.
DisAbility Confident
Quality Assurance and Control
LI-PFE
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