工作职责:

Main Purpose of the Role:

Deliver required Aseptic training within the facility, ensuring high quality learning interventions, complying with cGMP standards, corporate quality standards and local site SOPs. Partner with site training team and operations team to effectively design, develop and implement learning aseptic programs in support of business goals and site strategies and ensure that all colleagues and contingent workers are qualified to perform their GMP responsibilities in the Aseptic area.

Specific Responsibilities of the Role:

? Work in accordance with local procedures to comply with PQS Q1228, other PQSs (e.g. Aseptic PQSs) and meet all local regulatory requirements and quality standards relative to task.

? In partnership with Site Training team and Department Supervisors and Managers, ensure that training curricula are developed and maintained for all Aseptic activities and that these Curricula contain all necessary training for independent performance of the related GMP activities.

? Ensure that the training items that require periodic retraining/requalification are managed effectively.

? Support Department Supervisors to accurately determine their team / colleagues training status prior to assigning GMP tasks to colleagues and contingent workers.

? Ensure that effective Orientation Training programs and all necessary pre-requisite trainings are in place (Basic, Additional, departments / areas) for Aseptic Area Personnel.

? Ensure that training records are completed appropriately and maintained according to Pfizer record retention policies, and managed within the LMS (requirements include Curricula and training records - history and qualifications).

? Working with the Site Training team, and area SMEs, ensure that training methodology and the need for a learning assessment is determined via a documented risk analysis and effectively implemented for all Aseptic SOPs and other related GMP training topics.

? In partnership with area Supervisor, ensure that the process for managing learning assessment failures is defined and implemented effectively.

? Ensure that training deliveries are only from GMP Training materials that are controlled and retained.

? In the Aseptic area, ensure that processes are established to monitor training metrics and drive continuous improvement of the training system.

? Provide relevant training metrics to site Training Lead for reporting to SQRT on a 6 month basis the % Completion on critical Aseptic training and Annual GMP Training Progress.

? Maintain current knowledge of regulatory requirements and cGMP expectations for training.

? Support area Supervisors as required with auditors and Regulatory Agency inspectors in explaining the Training Quality System.

? Coach and support Aseptic SME team members to ensure flexibility of operations and improve engagement and individual development / growth to optimize training skills.

? Design and deliver learning interventions in support of area curricula requirements, site training objectives and business goals.

? Develop an area training plan to feed the Site Annual Training Plan to deliver Aseptic curricula Learning elements, including required GMP training, as well as other topics.

? Ensure that adequate technical training programs are in place to develop a competent workforce as per Aseptic Roadmap elements that support the site quality and performance metrics, and regularly evaluate the effectiveness of these learning and development programs, providing recommendations for improvement.

? Partner with site Training team and Regional Technical Learning and Capability lead to regularly assess the Training System (Aseptic Maturity Index, Learning System Scale and/ or Training Quality System Assessment) and implement learning solutions to meet site and OpU goals.

Note: Definition of GMP activity is any activity that is required by good manufacturing practice (GMP) regulations or registration requirements (reference PQS Master Glossary "GMP Related").

Support the Reduction of Learning Related Human Errors

? Partner with Quality Investigators and PHP Practitioners when there is a human error Learning Category to drill down to root cause and apply effective CAPA, associated with Aseptic Behaviours.

? Support and contribute to proactive human performance improvement (not just focus on training solutions). Use Aseptic SME, Behavioural feedback etc., in support of these activities

Build Training Knowledge and Skills

? Maintain a list of qualified Aseptic area trainers and SMEs to ensure that an effective Train-the-Trainer process is in place as needed.

? Implement effective communication and alignment between department Training Coordinators, Department Training Facilitators, and PLS Administrators (if relevant) and support their development.

? Ensure instructional design techniques and principles are applied to support GMP, job skills, and procedural training in Aseptic area.

? Where OpU or Regional training / learning forums exist, participate fully in representing the site, including Aseptic forums.

? Share programs and practices that have network wide applicability and be willing to take on consistent programs and practices to ensure network training effectiveness and efficiency.

任职资格:

Education & Experience:

? Significant, demonstrated competence and experience in Aseptic manufacturing environment, and strong micro knowledge.

? Solid understanding of the science behind to be able to explain the why).

? Demonstrated practical application of theory, with enough credibility in day-to-day Aseptic practice to be able to influence appropriate Aseptic behaviours (minimum 2-3 years

experience in manufacturing environment).

? Solid Knowledge of Aseptic Behaviours and Techniques.

? Bachelor

s Degree in education, training and development, microbiology or related field, instructional design or related fields; and/or demonstrated equivalent experience with proven success.

? Experienced in CI tools, e.g. M1, PHP LSS etc.

? Demonstrated competence in Instructional Design / Adult Learning, SOJT and task analysis.

? Strong competence in performance coaching.

? Excellent communication and presentation skills – deliver with passion and pride.