Production Supervisor - Flamma spa

Responsibilities:

• Provide critical input to the process R&D group so that projects can successfully be transferred from lab scale to Kilo/Pilot scale.
• Lead and facilitate root cause analysis investigations with site personnel to determine corrective action for process deviations.
• Define process critical parameters and safety aspects which can be affected by scale (time, operative conditions, equipment properties) in collaboration with R&D, Quality and HSE departments.
• Oversee manufacturing and cleaning operations ensuring they are carried out in cGMP compliance and following all the safety requirements.
• Planning daily activities of Operators in Pilot Plant, Kilo Labs and HPC Suite in collaboration with Director of Operations.
• Design and maintain the Production Schedule in collaboration with the Director of Operations.
• Participate in the preparation of annual CAPEX and OPEX budgets, proposing new investments with an appropriate rational.
• Draft Master Batch Records for execution.
• Review Executed Batch Records for approval.
• Draft and review campaign reports.
• Write and approve SOPs in collaboration with other departments.
• Train Operators in collaboration with R&D, HSE and Quality departments on the batch records before the execution of a manufacturing process.
• Coordinate and oversee waste management in collaboration with external vendors and HSE.
• Identify, analyze and mitigate potential safety hazards by conducting risk assessments during operations in the pilot plant/Kilo labs.
• Maintain all the manufacturing/operations equipment in compliance with cGMP regulations, where applicable.
• Provide technical input to facilitate qualification of manufacturing/operations equipment according to regulatory requirements.
• Assist in the preparation for, and interacting with various regulatory agency audits (i.e., FDA, DEA, OSHA, Corporate QA audits, in-house QA audits). Assists in keeping regulatory documentation current.
• Carry out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Comply with all company and site policies and procedures and the intent of our Credo.
• Assume responsibility for the safety, environmental, quality, and business effects of work performed.
• Successfully complete regulatory and job training requirements.

Qualifications:

• Bachelor’s Degree Chemistry, Chemical Engineering or related field OR an equivalent
combination of education and work experience - Master’s Degree Preferred.
• Minimum 10 years.
• Progressively responsible work experience in a high-volume, multi-product manufacturing
environment
• Significant experience leading and implementing lean manufacturing/Six Sigma initiatives.
• Solid knowledge of GMP and ISO regulations.
• Significant experience in identifying and driving operational change and excellence.
• Experience working in a broader enterprise/cross division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Strong leadership skills, including the ability to set goals and provide positive and
constructive feedback respectfully to build positive relationships and improve business
results.
• Ability to work effectively within a team in a fast-paced changing environment.
• Strong verbal and written communications with ability to effectively communicate at
multiple levels in the organization.
• Multi-tasks, prioritizes and meets deadlines in a timely manner.
• Strong organizational, planning, and follow-up skills and ability to hold others accountable.
• Ability to occasionally travel domestically and/or internationally.