Description
What you will do:
This role will be responsible for the oversight of the training program and documentation related to site compliance and inspection readiness, in collaboration with the Global GxP Learning Team, at Amgen India. The training manager is critical in ensuring all training activities are compliant with GMP/ GxP /GDP requirements and aligned with regulatory expectations. This position will play a critical role in providing support for Amgen India & Quality- Operations as well as participating in the GxP Learning Community of Practice.
**Key Responsibilities** :
+ Execute global GxP learning strategies and frameworks as defined by the Global GxP Learning Team.
+ Develop and implement learning / training material to support the site, business strategy and overall goals for Quality team
+ Lead the implementation and execution of training programs at the site level, ensuring alignment with GMP/GDP/regulations and internal quality standards.
+ Identify solutions in partnership with the Learning Ecosystem to identify and eliminate waste through learning technologies.
+ Provide site-level feedback to inform the continuous improvement of learning processes, tools, and content.
+ Support the AIN site and functions during regulatory inspections and audits, which may include reports, requests, or direct interface with inspectors/auditors.
+ Act as Subject Matter Expert on Learning operations specific to intake, overall LMS processes, and day to day activities.
+ Provide support in updating & delivering the trainings as per GMP/regulated requirements not limited to International requirements & Amgen’s Quality requirements to fulfill/comply with applicable regulations.
+ Participate in Community of Practice (CoP), driving continuous improvement, change management, and overall learning governance.
**Qualifications & Experience:**
+ Master’s / Bachelor’s degree and 9 to 12 years in Pharma and Biotechnology of Training & development, Quality , Operations
+ Experience in designing and implementing programs and initiatives from needs assessment through delivery for training based on the needs as per regulations & GMP requirements.
+ Biotech / pharmaceutical / GxP industry or experience in a highly regulated environment strongly preferred.
+ Strong change management skills and demonstrated ability to simplify and improve the business processes.
+ Effective verbal and written communication skills
+ Demonstrated creative problem-solving skills under resource constraints and time pressure.
