KEY RESPONSIBILITIES:

Delivery & Continuous Improvement:

Responsibility for batch release as per EU and US FDA guidelines by ensuring the following requirements have been met:

• Meet production schedule on a daily and weekly basis.
• Communicate and record any downtime or production stoppages to maintenance and your supervisor.
• Ensure all materials and equipment is available for the line to run smoothly
• Organise efficient line clearances, review cleaning logs and sign accordingly
• Communicate to people on the line – daily targets.
• Manufacture / pack product to GMP/FDA / regulatory standards as outlined in company documentation
• Accurate completion of all necessary documentation, and review of work orders prior to sign off.
• Carry out IPC checks as outlined in company documentation
• Ensure machines / equipment are maintained and working correctly
• Carry out minor machine / equipment adjustments as appropriate
• Clean machines / work area in accordance with standard operating procedures
• Assist with training as required by carrying out “on the job” training with process operators.
• Assist in preparation of new and review existing procedures
• Attainment of targets relevant to work centre
• Adherence to health and safety procedures
• Ensure compliance to documented procedures and GMP/FDA requirements as outlined in company procedures.
• Maintenance of hygiene / housekeeping standards in the production area
• Comply to terms and conditions outlined in your contract of employment

Quality
• Liaise with and collaborate with Quality Assurance to ensure that the product is being produced at acceptable levels of quality. Suggest improvements for quality where appropriate
• Completion and review of Manufacturing and packaging batch documentation when needed.
• Ensure SOP’s and CI’s are up to date in your work station
• Assist with the investigations and close out of deviations
• Assist with Internal and External Audits.
• Maintaining GMP / FDA Housekeeping at a high level within the department through the involvement of all team members

People
• The Production Line Lead will motivate production teams to achieve production KPI’s within their areas.
• Ensuring all performance issues are dealt with in a constructive and prompt manner and escalating to Production Supervisor where appropriate.
• Consistently applying Chanelle company values
• Facilitating open two-way communications with your team.
• Assist with employee on-boarding.
• Strive to ensure dynamic cross trained work force

Health & Safety
• Responsible for ensuring that all H&S policies and procedures are adhered to by driving H&S compliance.
• Responsible for ensuring that all site and emergency evacuation procedures are followed.
• Responsible for the reporting and completion accidents reports and near miss

COMPETENCIES:

• Proven Mechanical Knowledge/Understanding
• Organizational skills, personal efficiency, time management skills and the ability to prioritize competing demands are key communication skills.
• Ability to lead a team.
• Ability to build relationships and collaborate with others is vital.
• Ability to perform decision-making within the production area.
• Demonstrate and lead on the values, initiatives and culture of an organization. Professional expertise.
• A strong working knowledge of best practice processes, change management implementation, coaching and mentoring.
• Positive and proactive person who is energized by having great responsibility
• Practical, action-orientated approach to organize priorities and teams.
• Work consistently exceeds expectations of quality, quantity, customer service and timeliness
• Consistently resolves team problems and promotes improvements
• Demonstrates behaviors in line with the Company Values.

The above is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required.

QUALIFICATIONS:

• Minimum 4 years’ experience working in a regulated manufacturing FDA/HPRA environment
• Experience of operating technical equipment within a highly regulated manufacturing industry is essential.
• Experience of manufacturing process of either Solid dosage, Liquid dosages or operation of Blister Packing Machinery.
• Proven leadership capabilities. Experience as team lead, relief supervisor desirable.
• Proven Mechanical Knowledge/Experience 
• Excellent knowledge of GMP & GDP requirements desirable

PHYSICAL DEMANDS: Health & Safety requirements (eg. Manual Handling Training)

• Manual Handling

WORK ENVIRONMENT: (eg. Office, Production)

• Production, Warehouse