Quality Assurance

Role & responsibilities

Job Description

Experienced individual responsible for the local oversight and management of the Personnel & Training Management (P&TM) Level 2 process for the site. Ensures all elements of the training process are implemented, and in compliance with global standards. Provides expertise for the development of fit-for-purpose training materials and ensures alignment with regulatory and industry standards. Provides training expertise and support to GMP/GDP process Local Process Owner (LPO)s and partner with site departments to effectively design, develop and implement required training. Maintains oversight of the orientation training for new colleagues and contingent workers and manages locally required training programs, such as annual cGMP refresher training.

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

• 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: years of experience spanning Quality Assurance or Manufacturing function /Training & Technical Skill development /Research & Development or other experience in pharmaceutical environment.