Sop & Training Specialist

3 days ago

WaltononThames, United Kingdom Pfizer Full time

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

Role Summary

Responsible for ensuring high quality execution of controlled procedural documentation management and technical systems used for the conduct of business in clinical, medical, regulatory, safety and quality assurance organizations in compliance with regulations, laws, company policy and best practices.

Role Responsibilities

Review Local Procedural Documentation:

- Reviews global procedural documents to understand updates/changes
- Conducts central review of local procedural documents to determine if they are in compliance with the global procedure (impact analysis)
- Communicates with local procedural document authors to provide feedback on the central review outcome
- Documents outcome of central review

Periodic Procedural Document Assessment:

- Coordinates automated notifications to authors of impacted local procedural documents that periodic assessments are due
- Completes quality review of periodic assessments and communicates with local procedural document authors to provide feedback
- Tracks the status assessment completion to ensure implementation and compliance
- Issues escalation notifications to local authors who are non-compliant with periodic assessment requirements

Quality Control of procedural documents:

- Performs quality control checks for global procedural documents, by following internal processes and established standards within agreed timelines, including prioritizing multiple tasks for timely completion
- Performs quality control checks of information in the process management relational database.
- Supports documentation life cycle within the Global Document Management System (GDMS) and process management relational database to maintain a state of inspection readiness.
- Provides other documentation management support including, but not limited to GDMS searches, metrics,, technology initiatives and process improvement projects

Process Management Relational Database:

- Adds data/information into the process management relational database (i.e., a database that includes business process modeling and allows for management of controlled documents and associated information with an end user interface which provides the business access to internal colleagues, auditors, vendors, and regulatory authority inspectors) by collaborating with the SOP authors
- Completes data quality checks, periodic and ad hoc reviews of the process management relational database content including follow-up on resolution of potential content discrepancies.
- Supports the following: running of departmental metrics and other reporting activities; provides advice on process enhancements and continuous improvement, support resolution any questions about or issues arising from the Process portal, partake in user acceptance testing of new versions of the underlying portal management software or resolution of technical issues.

**Qualifications**:

- Minimum of a Bachelor’s degree or equivalent
- Demonstrated strong technical or digital skills in use of digital systems and new software
- Experience with design and documentation of pharmaceutical business processes (safety, regulatory, medical and/or clinical), or equivalent, such as experience of writing communications or training materials, intended for customers, or experience with process improvement projects and/or implementation of business process change management
- Experience of completing quality control review of pharmaceutical business process documentation (safety, regulatory, medical and/or clinical), or equivalent, such as quality control review of other types of documentation, training materials, presentations, communications or reports
- Experience of database maintenance, such as data entry, running reports and conducting data quality checks
- History of achievement in a customer service role with demonstration of meeting customer needs and concerns
- Can work independently to deliver high quality work within agreed deadlines
- Ability to manage multiple projectsand adjust priorities as needed
- Can interact at all levels within a matrix environment, globally and locally
- Strong English communication skills (verbal, written and listening) with ability to use a variety of communication tools and techniques to explain difficult issues and work to establish consensus
- Evident attention to detail
- Ability to maintain accurate and timely records
- Can adapt to changing situations and works well under pressure
- Ability to make decisions based on pre-set guidelines and procedures
- Ability to recognize issues and work

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