Training Manager

Job Description:

Designation: Training Manager

Education: Pharmacy/M. Pharmacy

Experience:

• Minimum 12-15 years of experience in production, training and development role in the pharmaceutical industry.

Technical Knowledge:

• In-depth knowledge of Manufacturing and Packaging process.
• In-depth knowledge of QMS, Batch record, Risk assessment, Qualification and cleaning validation.
• In-depth knowledge of Operation & Cleaning of pharmaceutical equipment’s and SCADA system.
• In-depth knowledge of data integrity requirements (ALCOA+ principles) and OOS/OOT investigations.
• In-depth knowledge of software used in production such as PAS|X, eLog, QMS, SAP, WMS, track trace system etc.
• In-depth knowledge of investigation related to Market complaint, OOS and implementation of CAPA.
• Should have expertise in preparation of PPT and Effective communication.

Key Responsibilities:

1. Training Needs Analysis (TNA):
   • Conduct thorough training needs assessments across all departments to identify skill gaps, and performance improvement areas.
   • Collaborate with department heads, supervisors, and subject matter experts (SMEs) to define specific training requirements based on operational changes, regulatory updates, and performance reviews.
   • Develop and maintain a comprehensive training matrix and annual training calendar.
2. Training Program Design and Development:
   • Design and develop engaging and effective training programs, modules, and materials for various learning formats (classroom, on-the-job training, simulations, etc.).
   • Ensure all training content is aligned with cGMP, regulatory requirements, and company-specific Standard Operating Procedures (SOPs).
   • Experience in developing and delivering training programs specifically for Quality Control (QC), Quality Assurance (QA), and Production functions in a cGMP environment. 

3. Training Delivery:
   • Lead and facilitate training sessions and workshops from entry-level to senior staff.
   • Provide coaching and support to internal trainers and SMEs.
   • Supervise the training programs, including scheduling, and participant coordination.
4. Training Effectiveness Evaluation:
   • Develop and implement robust evaluation methods to assess the effectiveness of training programs (e.g., pre/post-assessments, performance observations, feedback surveys).
   • Analyse training data and metrics (e.g., completion rates, competency improvements) and identify areas for improvement.
   • Provide regular reports on training effectiveness to management.
5. Compliance and Documentation:
   • Ensure all training activities and records are documented and maintained in compliance with cGMP and regulatory requirements.
   • Manage and utilize the Training Management System (TMS) for tracking training progress.
   • Ensure the compliance to new guidelines.
6. Continuous Improvement:
   • Stay up-to-date of industry trends, new technologies, and training methodologies.
   • Proactively recommend and implement improvements to existing training programs and strategies.
   • Promote a culture of continuous learning and development within the organization.