The LPO (P&TM) co-creates and supports the Pfizer Global Supply (PGS) training strategy by closely working with global training partners. Collaborates with Global Process Owner (GPO) Personnel & Training Management (P&TM) to support PGS training strategy. Acts as an active member of the P&TM Center of Excellence (CoE) and supports the Global Learning Team/Training CoE with development of GMP/GDP process curricula and instructionally sound training materials.
Responsibilities
- Ensures the appropriate process for managing CVs and JDs is followed at site for employees performing GMP/GDP activities and those responsible for quality GMP/GDP decisions require JD/CVs
- Functions as a curriculum owner for their process and execute periodic curriculum content review.
- Reviews the risk-based approach for completeness and checks if chosen training and/or evaluation methods are aligned with the training modality.
- Works closely with other Process Owners and SMEs for Training Risk Analysis (TRA) and Learning Needs Assessment (LNA).
- Works with the learning specialists and people leaders to determine curricula structure and learning plan and ensures (global) curricula are assigned to local role holders.
- Ensures that all employees have an up-to-date learning plan as per job specific role. This is in collaboration with Process Owners to ensure the right curricula are assigned to the right roles.
- Maintains Oversight of the orientation training and Job specific learning plan assignment for new colleagues and new contingent workers.
- Accountable for overseeing the process for Training After Long-Term Absence from Role.
- Responsible for developing and establishing a train-the-trainer curriculum (e. g. , TTT program) at site.
- Ensure an effective training administration process with adequate resources.
- Ensure an effective and appropriate process for the management of waivers and substitutes.
- Ensures training materials are stored and controlled in the local document repository/content server.
- Oversees and monitors PDOCS activities associated with SOP, SOJT and other training materials revision.
- Measures and reports on key performance metrics defined globally and aligns to established targets. Determines improvement actions as needed.
- Reports quality specific performance metrics for training to Site Quality Review Teams (SQRTs).
- Responsible for monitoring overdue trainings at site.
- Represents the Personnel and Training Management system during audits.
- For regulatory / Board of Health (BOH) audits: Partners with business operations to complete preparation and inspection readiness activities to ensure adherence to current P&TM global SOPs and global/local work instructions (WIs); Liaises with the GPO P&TM to discuss risk and develop necessary CAPA(s) for observation(s), as needed.
- Ensures the BCP process is sustained during an outage.
- Maintains SASO (site administration access) in the PLA.
- Be vigilant for potential actions or behaviors that could result in breaches of GMP compliance or Data Integrity principles .
- Engages with Executive Sponsor and key partners to enable training strategy.
- Supports the Global Learning Team/Training CoE with development of GMP/GDP process curricula and instructionally sound training materials.
Technical Skills
- Expert in communication and presentation of technical content
- Expert in developing training programs such as Train the Trainer.
- Understanding of facilitated learning modalities/ methodologies.
- Understanding of the risk-based approach to training design
- Awareness of training theory, learning styles, and instructional design
- Skilled in Training design and delivery methods
- Understanding of importance of GMP/GDP training in a pharmaceutical manufacturing environment
Core Competencies:
- Expertise in content development
- Technical writing skills
- Knowledge of e -learning
- Expertise in developing Fit of Purpose training curricula.
- Must have excellent content research & content editing skills.
- Conceptual knowledge of pharmaceutical industry and related subject matter expertise.
Experience: 12-15 years of experience spanning Quality Assurance or Manufacturing function /Training & Technical Skill development /Research & Development or other experience in pharmaceutical environment.
