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Group Lead V. Mfg

February 14, 2019 8:36 PM | Anonymous member (Administrator)


Overview:

Shift coordination of Manufacturing activities. Maintain a technical understanding sufficient to provide front-line instruction for production issues.  Assume responsibility for the GMP, environmental health and safety procedure awareness, and compliance within the respective area. Support OpEx initiatives, efficiency, and continuous improvement.

Duties:

  • Personnel Supervision. Supervise personnel in support of Compounding and Aseptic Prep activities in the pursuit of daily excellence. Assign work to manufacturing personnel. Coordinate the daily workflow with Group Leaders from other shifts.
  • Production Scheduling. Work directly with the Planning Department in development of the production schedule. Identify equipment and personnel requirements and provide solutions for constraints. Coordinate shift activities and facilitate the transfer of activities between shifts. Communicate with internal customers as frequently as required. Coordinate and escalate equipment issues with appropriate technical resources.
  • Personnel Training and Development. Oversees technical training of personnel. Mentors new personnel in behaviors and job expectations. Engages in the identification of training plan based on business needs.  Reports progress to the Team Leader. Participates in development of training plan. Ensures SOP’s are read; provides technical SOP training.
  • Compliance. Understands and enforces daily area compliance in safety/EHS procedures, GMP, and SOP/batch record adherence. Audits area compliance. Evaluates quality performance with the Team Leader and/or Manufacturing Quality Assurance.
  • Operator Substitution. Perform manufacturing compounding and/or aseptic prep operator functions when necessary.
  • Projects. Participate on project teams and R&D projects. Coordinate new product Process Validation and Cleaning Validation activities. Attend GMP training sessions as scheduled.  Represent Manager in project meetings.  Serve as leader of Operational Excellence Projects.  Support OpEx and WISE OWLS initiatives. 
  • Documentation. Review area documentation including batch records and logbooks as necessary.

Requirements:

5+ years of sterile pharmaceutical experience. Understanding of compounding, aseptic prep, aseptic filling or packaging including batch preparation, general CIP/SIP, sterilization and cleaning principles.  Proven experience leading people, Multi–tasking, and risk assessments.

Special Skills:

Excellent math skills, detail oriented, good communication skills and leadership abilities. Mechanical aptitude to understand principle of operation of various compounding and aseptic prep equipment, self-initiative. Customer service. Ability to work with multiple technical and business disciplines. Understand and apply general chemical, microbiological, and engineering/physics principles. Makes sound business decisions. Must have a general understanding of “why” activities are performed as a daily tool in making sound decisions and troubleshooting problems. Good written and verbal skills. Computer skills (email, word processing, basic spreadsheet). Makes decisions based on data when possible.   

Apply Here:   www.bauschhealth.com/careers 

Bay Area Manufacturers Association

P.O. Box 167

1324 Seven Springs Blvd

New Port Richey, FL 34655 

727-536-5809

admin@bama-fl.org

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