Training & Documentation Compliance Sr. Specialist
il y a 1 semaine
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.
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.
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.
- 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.
- 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.
- 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.
- 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 endusers in coordination with PGS BT
- Manage following activities in the system: reactivate users, manage group membership,update template content, manage dynamic views, manage user list rules, keep cabinet GRC documentation uptodate (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 daytoday operational support to endusers.
- 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
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