Lead Operator/Operations Process Lead is responsible for the execution of day to day manufacturing activities and working with support organizations to ensure all operations run safely, smoothly, compliantly and delivery commitments are met. This role reports directly to the Operations Supervisor and deemed a functional technical expert for Manufacturing process matters in the company.
Operational Responsibilities:
- Provide leadership on Environmental, Health and Safety policies and procedures by taking EHS into account when planning and executing activities.
- To ensure compliance with the Pharmaceutical Quality System and takes all measures capable of improving its implementation.
- To ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality.
- To approve the instructions relating to production operations, including amendments and to ensure their strict implementation.
- To ensure that the production records are evaluated and signed by an authorise Person.
- To ensure the qualification and maintenance of the department, premises and equipment.
- To ensure that the appropriate validations are done.
- To ensure that the required initial and continuing training of the department personnel is carried out and adapted according to need.
- To ensure the manufacturing environment is appropriately monitored and controlled.
- To ensure a high standard of plant hygiene.
- To ensure compliance with cGMP and cGDP practices in Operations.
- To recommended & implement actions for/from Management Reviews of process performance, product quality, and of the Quality Management System.
- Ensure successful HPRA and FDA inspections, by consistently ensuring that the high level of quality compliance is maintained, and wherever possible improved.
- Work with all site functions on new product introduction, developing pilot lines, introducing new manufacturing equipment and developing related sop's and forms.
- Execute and coordinate employee training to ensure that procedures are followed and meet all quality requirements.
- Use problem solving skills to ensure stable operation of the manufacturing area.
- Report problems or concerns with safety, quality, processes, equipment, materials and labour to Operations Supervisor, Head of Operations or designee.
- Work closely with support staff such as Technicians, Manufacturing Engineering, Manufacturing Manager, Quality, Materials/Warehouse to resolve issues.
- Observe, maintain, coordinate and complete standard work.
- Update production metrics and facilitate regular team communication.
- Identify and support continuous improvement efforts with team leads.
- Sustain and drive lean manufacturing and 5S activities.
- Maintain oversight and participate as an active member of the manufacturing team in execution of responsibilities in BMR's, BPR's, PQ's, Protocols and other required manufacturing activities.
- Follow detailed assembly instructions, processes and procedures.
- Complete required documentation relating to business and regulatory requirements.
Leadership:
- Continue to technically develop the team, raising the standards to become "best in class".
- Provide technical performance and capability feedback on operators to supervisor to aid personnel development.
- Represent Amneal with key stakeholders, from clients to regulatory agencies as a process SME.
- Activities other than those defined in the Job Description are to be carried out, as per the requirement of Head of Department and by following Head of Department's (or approved deputy) instructions.
- In absence of the employee named above, the designated Senior Manager, Technical Operations is responsible for day to day activities/duties.
