Training & Documentation Compliance Sr. Specialist

WHY PATIENTS NEED YOU

Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.

JOB FOCUS

This function is responsible for the development, implementation and maintenance of training and documentation compliance requirements of all functional areas in IO including the Logistics Centers in Zaventem, Singapore, Panama as well as SC&ESQ GDP supporting IO.  Maintains positive and cooperative communication and collaboration with key stakeholders at all levels of the organization and operates in close collaboration with the Quality Compliance Team. 

The key role of the Senior Training & Documentation Compliance Specialist is to ensure that all procedural documentation and training records meet business and regulatory requirements and are consistent with the IO GDP Quality Management System (QMS).

She/He acts as Designated Point of Contact (DPoC) and Subject Matter Expert for the documentation management system PDOCS and the training management system PLS and is responsible for all enhancements and continuous improvements.  Strengthens Human Performance Culture and innovative learning methods and technology for increased documentation and training effectiveness, competency and growth.

This function drives all areas of the Documentation Lifecycle Management and Training Quality System, ensures availability of evidence for internal and external audit purposes and creates performance metrics to allow business owners to mitigate compliance gaps.

As subject matter expert (SME) in the areas of Procedural Documentation Management and Training Management, this function is also a critical partner during projects and new process deployments to ensure there are no compliance gaps and requirements are in place.

Acts as back up of the TL/Manager.

JOB SUMMARY - MAIN AREA’S OF RESPONSIBILITY / ACCOUNTABILITIES

Categorize the key areas (max 8) of responsibility. Divide these areas into steps outlining only the “main” activities per area.  Assign a percentage of time spent on each major category (if applicable).

SME role and Back up TL/Manager

• Represent Training & Documentation in IO process centric teams and projects: own actions, drive resolutions and escalate where necessary.
• Ensure that standard work is documented, followed and current version is maintained and trained.
• Monitor IO performance, adherence to Training & Documentation process, standards and compliance.
• Point of contact and SME for Intercompany Operations.
• Align and coordinate within IO and SC&ESQ GDP supporting IO on continuous improvement processes.
• Monitor the PDOCS/PLS Interface (PPI) movements, check and assign training, solve issues.

Training Management

• Organize all types of learning activities for Intercompany Operations (IO) and SC&ESQ GDP department.
• Manage storage of all functional and business process training documentation.
• Support and coordinate trainers within IO on creation/updates of training material and assessments to ensure training effectiveness.

Procedural Documentation Management

• Support and coordinate the update and creation of procedural documents for Intercompany Operations (IO) and SC&ESQ GDP department.
• Initiate and follow up on periodic review of procedural document Support authors on technical writing skills for increased documentation effectiveness.
• Implement improvements based on shared practices in the DPOC Community.

Inspections & Reporting

• Create training and documentation metrics and reports supporting business.
• Create and deliver Monthly and Quarterly SQRT reporting.
• Support internal and external inspections with providing evidence.
• Support and execution of CAPA’s and mitigation plans of any concluded findings and gaps.

PDOCS – Operation and Maintenance of GSC Cabinet

• Designated Point of Contact (DPOC)

  • Align with other site administrators within the GSC cabinet on property changes to do, keeping the baseline documentation up to date. Providing support towards other site administrators within the PDOCS cabinet.
  • As SME provide operational support to PDOCS end-users in coordination with PGS BT
  • Manage following activities in the system: re-activate users, manage group membership,update template content, manage dynamic views, manage user list rules, keep cabinet GRC documentation up-to-date (PVA, SVBCD, VCR)
  • Ensuring local site change control is created and approved.
  • Provide completed and approved SVBCD.
  • Participate in monthly user group meetings and harmonize PDOCS approaches and processes moving towards innovation and CI.
  • Liaise with PDOCS Production Support team to provide day-to-day operational support to end-users.
  • Facilitate and encourage communication across functional units and sites in the PDOCS Logistics Distribution Center (LDC) Domain’.

• Site Administrator

  • Submit request for creating/updating Dynamic views and Lifecycle Extensions
  • Create/Update Pfizer Value Assistance objects (PVAs)
  • Import/modify Document templates
  • View and export PVA Manager reports
  • Create/Update public saved searches

• Doc Class Manager

  • Change a workflow supervisor
  • Set effective dates

• Author/Reviewer/Approver

  • Create//Edit/Delete documents in all statuses
  • Route documents through various workflows
  • Review and Approve documents routed through workflows

• Webviewer maintenance and creation of dynamic views for stakeholders in the GSC cabinet

PLS – Operations and Maintenance of IO domains and Global

• Implement improvements based on shared practices in the PLS Common Interest Group (CIG).
• Represent IO interests in the PLS community.
• Support the PLS Core team with fully testing our configuration and custom solutions in case of a vendor release to ensure they continue to work as per our requirements.
• Support the IO PLS Admins with knowledge enhancement and issues.
• Provide technical support to PLS end users.
• Manage the IO training roll-out for Global use.
• Set-up new and manage existing parameters and structure for automatic assignments.
• Investigate the periodic monitoring reports and solve issues.
• Create and update learning items and online content for courses and assessments.
• Create and update user profiles, job codes, assignment profiles and training curricula.
• Create and maintain instructor profiles.
• Manage waivers, training records and materials.

KEY PERFORMANCE INDICATORS (KPI)

• Timely creation and availability of all audit and operational reports
• Provide quality and accuracy of documentation and information to stakeholders
• Timely roll-out documentation and training content to Intercompany Operations (IO) and Quality GDP department colleagues 
• Avoid Human Error incidents by embedding PHP into documentation review, training methodology and effectiveness
• Meet set departmental and individual objectives
• Works according to relevant SOP / WI

QUALIFICATIONS

• Level of Education

Bachelor in Administration or equivalent by experience 

• Experience

Min. 3 years of experience in the field of administration, reporting, compliance and office management

• Languages

Languages: Fluent in English (required), French and/or Dutch (advantage) 

• Computer skills

Intermediate to advanced knowledge of Excel, Word, PowerPoint, Visio. Must be proficient with Word References and Styles, Excel pivots, basic formulas. Snagit and Movie Maker are an advantage. 

• Other Specific know-how 

Good knowledge of the Pfizer procedures and policies 

ARI, PLS, PDOCS knowledge is an advantage

COMPETENCIES – PERSONAL CAPABILITIES

• Attention to detail and accuracy

• Communication skills (written and verbal)

• Strong planning and organization skills

• Stress resistant and ability to deal with tight deadlines

• Problem solving oriented

• Initiative for continuous improvement 

• Flexible team player

• Open minded

• Customer oriented

• Demonstrate Equity, Joy, Excellence, Courage

OUR OFFER

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. Pfizer's open-door policy is an integrated part of our culture across all levels of seniority.

We offer possibilities for working from home (up to 3 days per week) and flexible working hours.

Competitive salaries and benefit packages : DKV hospitalisation, outpatient, life and disability insurance, pension plan, in-company restaurant, phone, public transport reimbursement, ...

Unparalleled opportunities for career growth: trainings, possibilities for internal mobility, temporary assignments…

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.

Pfizer discovers, develops, manufactures and distributes medicines and vaccines. Pfizer wants to contribute to better health and wellness for everyone, at every stage of life. Pfizer works with the government and other health partners to provide quality and accessible healthcare. The patient is central to this story. 

Pfizer has four offices in Belgium with which it supports its Belgian and international activities: 1) Anderlecht, where the Pfizer Clinical Research Unit is located. This is a fully equipped phase 1 research center. With that of New Haven (US), it is one of two Phase 1 Pfizer research centers in the world, 2) Elsene_, the Belgian headquarters, 3)_ Puurs_, Pfizer's production and packaging site, and 4) Zaventem, the international Pfizer's Logistics Center._ 

More information can be found at www.pfizer.com, www.pfizer.be and on Facebook and Twitter. 

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