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DGM QA Training


Visakhapatnam, AP 530003
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Job Details

**Role Title:**

Site Training Lead GMP

**Main Purpose of the Role:**

Develop, oversee and maintain the Training Quality System for the site / location; ensure the Training Quality System complies with cGMP standards and corporate quality standards. Partner with site management team to effectively design, develop and implement learning and development programs to support business goals and site strategies and ensure that all colleagues and contractor workers are qualified to perform their GMP responsibilities. Maintain Visual Inspection and Contingent Workers Training Program .

**Specific Responsibilities of the Role:**

**Maintain a Compliant Training Quality System**

+ Develop and update local procedures to comply with global procedures and meet all local regulatory requirements and quality standards.

+ Ensure that all elements of the Training Quality System are maintained compliantly, including:

+ GMP Training Materials

+ GMP Training

+ Learning Assessments

+ Orientation Training

+ Trainers

+ Training Curricula

+ Training Methodology

+ Training Records

+ Training System Metrics

+ CBT Program

+ Visual Inspection Training Program

+ Visual Inspection Training Defect Kits

+ Contingent workers Training Program

+ Partner with Department Training Coordinators and Department Supervisors and Managers to ensure that training curricula are developed and maintained for all GMP activities and that Training Curricula contain all necessary training for independent performance of the related GMP activities.

+ Partner with Department Training Coordinators and Department Supervisors and Managers to ensure that Training Curricula are deployed in a timely manner to all colleagues and contractor workers performing GMP activities in the department / area.

+ Define the process for the control and update of Training Curricula and implement the process for periodic review of Training Curricula.

+ Define which training topics require periodic retraining/requalification and implement 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 are in place (Basic, Additional, departments / areas).

+ Ensure that training records are completed appropriately and maintained according to Pfizer and Vizag site record retention policies, including the specific records related to Consultants .

+ Ensure that the relevant LMS (Learning Management System) or manual tracking system is properly maintained for training requirements (Curricula) and training records (training history and qualifications).

+ Ensure that training methodology and the need for a learning assessment is determined via a documented risk analysis and effectively implemented for all SOPs and other GMP training topics.

+ Ensure that the process for managing learning assessment failures is defined and implemented effectively.

+ Maintain the training risk analysis documents in a secure folder, separate to the related SOP.

+ Ensure that ongoing GMP Training is conducted annually, with topics being determined by analyzing relevant needs for the site / location and ensuring that the training is relevant to colleagues' roles and responsibilities.

+ Ensure that GMP Training materials are controlled and retained.

+ Establish and monitor training metrics and drive continuous improvement of the training system. At a minimum, report to SQRT on a monthly basis the % Completion and Annual GMP Training Progress.

+ Maintain current knowledge of regulatory requirements and cGMP expectations for training

+ Act as the interface with auditors and Regulatory Agency inspectors in explaining the Training Quality System.

+ Where appropriate, lead site training team; coach and develop team members to ensure flexibility of operations and improve engagement and individual development / growth to optimize training skills.

+ Manage and maintain compliant, comprehensive visual inspection training program

+ Manage and maintain compliant, comprehensive contingent/contractor training program

Note: Definition of GMP activity is any activity that is required by good manufacturing practice (GMP) regulations or registration requirements

**Specific Responsibilities of the Role (continued):**

**Oversee Site Training Strategy**

+ Develop and communicate site training objectives annually and, where appropriate, conduct an annual review of the site Training System (Annual Training Review) and share with SQRT for endorsement and feedback.

+ Develop an Annual Training Plan that includes required GMP training, as well as other topics.

+ Partner with the Vizag Learning University to ensure that adequate foundation training programs are in place to develop a competent workforce that supports the site quality and performance metrics, and regularly evaluate the effectiveness of these learning and development programs, providing recommendations for improvement.

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

**Support the Reduction of Learning Related Human Errors**

+ Partner with Investigators when there is a human error Learning Category to ensure appropriate root cause identification and effective CAPA.

+ Support and contribute to proactive human performance improvement (not just focus on training solutions).

+ Partner with Investigators where training is a part of the possible root cause

**Build Training Knowledge and Skills**

+ Maintain a list of qualified trainers and ensure that an effective Train-the-Trainer process is in place.

+ Ensure the PLS System Owner is qualified to perform the role of PLS Administrator for the site and that changes to the PLS Site / System Owner role are communicated to the Regional TL&C Lead.

+ Implement effective communication and alignment between Training Coordinators, Department Training Coordinators, and PLS Administrators and support their development.

+ Ensure instructional design techniques and principles are applied to support GMP, job skills, and procedural training.

+ Develop innovative communications and opportunities for colleagues to learn and be engaged in the training process and related LMS (e.g. PLS, P2L).

**Be a Corporate Training Citizen**

+ Liaise with TL&C Regional Training Lead on a regular basis (e.g. monthly), through formal touch-base.

+ Share site training objectives and Annual Training Review (if appropriate) with TL&C Regional Lead.

+ Represent the site on Training communications and interactions (e.g. receiving PQS Training notifications).

+ Receive and actively communicate across the site to ensure the completion of Enterprise Trainings (e.g. Your Reporting Responsibilities, Blue Book, etc.).

+ Be active in the Learning CoP and related CIGs (e.g. GMP, PLS) with regular attendance at meetings, sharing practices and replicating.

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

+ 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.

**Organizational Relationships:**

**Reports to:** Site Quality Lead

Note: reporting relationship should ensure that this role has the credibility and influence with senior leaders to ensure technical training and the acquisition of skill is given appropriate attention at the site . This is critical so that they understand the strategic role of the site within the network and have the ability to interpret future skill requirements from the short, medium and long term objectives of the site.

**Interacts with:** Site Leadership Team / SQRT, Department Managers, Regional TL&C Lead, other TL&C team member, other Pfizer sites.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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