Line Lead - 3 Shift Rotating Cycle
About Chanelle Pharma:
Chanelle Pharma is Ireland’s largest indigenous generic pharmaceutical manufacturer of both medical and veterinary products.
Serving customers in 96 countries worldwide, Chanelle Pharma is a partner of choice in the development and manufacturing of pharmaceutical products to the world’s leading human generic and animal health multinationals and distributors. We are passionate about understanding and addressing the challenges facing our medical and veterinary customers and bringing them innovative and effective products and solutions.
This is an opportunity to be part of a dynamic team within the Production and Manufacturing function. We are looking for individuals who will support and drive Chanelle Pharma’s vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to provide excellent services and support to our customers.
In this role you will report into Production Supervisor
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
• 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
• 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
• 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.
• 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