Director Aseptic Compliance, Training Material & Batch Release

Responsibilities

• Results Expected/ Target
  • Financial Preparation of Revenue and Capex Budget.
    • Ensure financial prudence in resource planning, allocation and manage within approved budgets while building best in class quality processes and systems at site
    • Maintain quality system controls to ensure no critical and major market complaints
    • Take appropriate steps to reduce wastages and losses in the analysis process and build improved efficiency.
  • Operational Excellence
    • Develop the various positions and roles and responsibilities necessary for the Aseptic Compliance and Training Department.
    • Lead the development and implementation of policies and procedure as required to support the day to day activities of the department including periodic evaluation by shop floor oversight.
    • Lead the development and administration of the aseptic behavior certification program for employees working in the manufacturing aseptic environment including operational staff, cleaning staff, microbiology, maintenance staff, etc.
    • Lead the activities required to develop and deliver GMP training modules related to proper aseptic behavior and maintaining an aseptic environment.
    • Lead efforts to drive continuous process improvement activities with the dual goals of reducing risks of contamination, reducing waste, increasing process efficiency, and reducing safety hazards.
    • Coach and mentor employees on the importance of maintaining low bio burden during line clearing/cleaning, runs, routine and non- routing interventions.
    • Maintain working knowledge of cGMPs and emerging regulatory and compliance concerns as related to sterile manufacturing.
    • Assess work environment to ensure it is suitable to enable good aseptic behaviors and makes recommendation to management on changes needed.
    • Partner with Operational and Environmental Control staff in supporting the investigation of events linked to microbial contamination and in particular, defining CAPA’s associated with human aseptic practices.
    • Lead the training program for the site from QA perspective including but not limited to curriculum, timely completion of assigned training, providing feedback to QADC for implementation of documents based on training completion etc.
    • Responsible for tracking and trending matrix associated with batch record errors and right first time concept at site and providing leadership on reducing errors and timely disposition of materials and products manufactured.
  • Stakeholder
    • Ensure compliance with Standard Operating Procedures (SOPs), Forms, Batch Production Records, Protocols, as needed.
    • Participate in cross-functional risk assessments and process parameter classification.
    • Participates in continuous improvement efforts in quality systems through the evaluation of trends in key performance indicators, audit and stakeholder feedback, and corrective/preventative actions.
    • Participate on interdepartmental project / program teams to meet company / site milestones and objectives.
    • Responsible for management of Batch Release, Raw material and Packaging Material releases.
    • Responsible for support of and coordination with all cross functional teams for documentation needs within the site for materials and batch release.
  • Innovation
    • Operate in compliance of cGMP, 21CFR, USP, EP and ICH regulatory requirements.
    • Provide technical assistance in upgrades and improvement of facility design to meet current industry practices.
    • Stay abreast of industry and affiliated publications, memberships, and technologies to ensure organizational goals are met.
    • Actively seek out new, cutting edge technology to further Quality Operations initiatives and build efficiencies.

Qualifications

Required Qualifications:

• Bachelor’s degree in Microbiology, Biotechnology, Pharmaceutical Sciences, or a related field.
• Minimum of 5 years of experience in aseptic manufacturing, preferably in a pharmaceutical setting.
• Experience in developing and implementing training programs and certifications.
• Knowledge of cGMPs, FDA regulations, and industry standards.
• Strong communication and interpersonal skills.
• Ability to lead and mentor a team.
• Experience with Lean Six Sigma methodologies is a plus.

Skills

Essential Skills:

• Excellent communication and interpersonal skills.
• Strong problem-solving and decision-making abilities.
• Ability to work independently and as part of a team.
• Proficiency in Microsoft Office Suite.
• Experience with GMP training and certification programs.
• Knowledge of cGMPs, FDA regulations, and industry standards.
• Ability to assess and improve work environments to promote good aseptic behaviors.
• Experience with Lean Six Sigma methodologies is a plus.