Training Manager (Pharma Quality Assurance) (Location: Palghar)

Role & responsibilities

The Pharma Training Manager is responsible for designing, implementing, and managing training programs related to Good Manufacturing Practices (GMP), Quality Management Systems (QMS), and regulatory compliance within the organization. This role ensures that all employees are trained in accordance with regulatory requirements and company policies, fostering a culture of quality and compliance.

Key Responsibilities:

1. Training Program Development & Execution

• Develop, implement, and oversee GMP and QMS training programs for all employees, ensuring compliance with regulatory standards (FDA, EU-GMP, ICH, WHO, etc.).
• Conduct new employee induction training and ongoing refresher training for existing staff.
• Design and deliver on-the-job training (OJT), classroom sessions, virtual training, and workshops on quality and compliance topics.
• Maintain and update training materials, manuals, and SOPs based on regulatory changes and internal requirements.

2. Compliance & Quality Management System (QMS) Training

• Ensure training programs align with regulatory requirements, internal policies, and industry best practices.
• Provide training on deviations, CAPA (Corrective and Preventive Actions), change control, investigations, and risk management.
• Educate employees on data integrity, document control, and good documentation practices (GDP).
• Ensure training on internal and external audit preparedness, regulatory inspections, and continuous improvement initiatives.

3. Training Administration & Documentation

• Maintain accurate training records, including training logs, attendance, competency assessments, and qualification reports.
• Develop and track Key Performance Indicators (KPIs) to assess training effectiveness and compliance.
• Conduct periodic training assessments and implement improvements based on feedback.
• Ensure training documentation is readily available for regulatory audits and inspections.

4. Cross-functional Collaboration & Continuous Improvement

• Work closely with QA, Production, R&D, Engineering, HR, and other departments to ensure training needs are met.
• Support the development of a Quality Culture by promoting knowledge sharing and awareness programs.
• Stay updated on industry trends, regulatory updates, and emerging best practices to enhance training programs.

Preferred candidate profile

• Education: Bachelors/Master’s degree in Pharmacy.
• Experience: 15-20 years of experience in Pharmaceutical Quality Assurance (QA), with a strong focus on regulatory compliance.
• Skills & Competencies:
• In-depth knowledge of GMP, QMS, regulatory guidelines (FDA, EMA, WHO, ICH, MHRA, etc.).
• Strong understanding of CAPA, risk management, deviations, and audits.
• Excellent communication, presentation, and facilitation skills.
• Proficiency in using Learning Management Systems (LMS) and training software.
• Ability to motivate and engage employees in a structured training environment.
• Experience in handling regulatory audits and inspections.
• Proficiency in digital training tools and e-learning platforms.

Perks and benefits

Salary as per market with ESOPs and multiple plant exposure.