Job Description

Summary
To lead and coordinate site-wide training initiatives and drive the Right First Time (RFT) culture across the injection manufacturing facility. This role ensures that all personnel are adequately trained and that manufacturing processes are optimized to deliver quality products on the first attempt, minimizing rework, waste, and deviations.

1. Training CoordinationDevelop and maintain a comprehensive training matrix for all manufacturing roles. Coordinate onboarding and continuous training programs for operators, technicians, and supervisors. Ensure training records are accurate, up-to-date, and compliant with regulatory requirements. Conduct training effectiveness assessments and identify skill gaps. Collaborate with SMEs to develop SOPs, work instructions, and training materials.

2. Right First Time (RFT) ImplementationPromote a culture of "Right First Time" by embedding quality into every step of the manufacturing process. Monitor and report RFT metrics (e.g., batch success rate, deviation rate, rework incidents). Lead root cause analysis (RCA) and corrective/preventive actions (CAPA) for RFT failures. Facilitate cross-functional Kaizen or Lean Six Sigma projects to improve RFT performance. Support implementation of Statistical Process Control (SPC), FMEA, and other quality tools.

3. Compliance and DocumentationEnsure all training and RFT activities comply with cGMP, ISO, and regulatory standards. Participate in internal and external audits, providing training and RFT documentation as required. Maintain audit readiness of training systems and RFT documentation.

4. Cross-functional CollaborationWork closely with Quality Assurance, Production, Engineering, and HR to align training and RFT goals. Act as a liaison between shop floor teams and management to ensure continuous improvement.

Qualifications:Bachelor's degree in pharmacy, Life Sciences, Engineering, or related field. Minimum 10 - 15 years of experience in pharmaceutical. Strong knowledge of cGMP, and quality systems. Experience with training systems and electronic documentation tools (e.g., Compliance wire, Track Wise). Excellent communication, facilitation, and analytical skills.

Key Competencies:Attention to detail and quality mindset Proactive problem-solving Strong organizational and project management skills * Ability to influence and drive change across teams