Staffline are searching for an experienced Line Lead for a 3 Shift Rotating Cycle located in Co. Galway for our Client -one of Ireland's largest pharmaceutical manufacturers, serving customers in 96 countries worldwide.
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 our Client'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
* 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 process equipment are available for the line to operate and function at full optimum capabilities.
* 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, working correctly and perform routine process and automation checks.
* Carry out 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
* Review of engineering documentation.
* 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 CIs are up to date in your workstation.
* 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 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 company values
* Facilitating open two-way communications with your team.
* Assist with employee on-boarding.
* Strive to ensure dynamic cross trained work force.
* 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 misses.
* Proven leadership capabilities with the ability to build relationships and collaborate with others.
* Experience as team lead, relief supervisor and ability to resolve team problems and promote improvements.
* Excellent decision making, communication & interpersonal skills required.
* Organizational skills, personal efficiency, time management skills and the ability to prioritize competing demands.
* Demonstrate and lead on the values, initiatives and culture of an organization.
* A strong working knowledge of best practice processes change management implementation, coaching and mentoring.
* Practical, action-orientated approach to organize priorities and teams.
* Work consistently exceeds expectations of quality, quantity, customer service and timeliness.
* Bachelor's degree in pharmacy, Pharmaceutical Sciences or engineering preferred.
* Minimum 4 years' experience as subject matter experts in operating technical pharmaceutical equipment and running fully automated pharma manufacturing processes and pharmaceutical product lines.
* Proven experience of set up and operating of the Pharmaceutical Machine Line equipment and processes for Solid dosage, Liquid dosages and or Blister Packing Machinery.
* Strong Knowledge and technical know-how in process automation essential
* Excellent knowledge of GMP/GDP/FDA and HPRA requirements essential
PHYSICAL DEMANDS: Health & Safety requirements (e.g., Manual Handling Training)
WORK ENVIRONMENT: (e.g., Office, Production ) Reporting to a Production Supervisor you will be responsible for batch release as per EU and US FDA guidelines by ensuring production schedule is met on a daily and weekly basis and some responsibilities will include:
- Communicating and recording any downtime or production stoppages to maintenance and your supervisor
- Ensuring all materials and equipment is available for the line to run smoothly
- Organising efficient line clearances, review cleaning logs and signing accordingly
- Manufacture / pack product to GMP/FDA / regulatory standards as outlined in company documentation
- Ensure machines / equipment are maintained and working correctly
- Carry out minor machine / equipment adjustments as appropriate
- Assist with training as required by carrying out "on the job" training with process operators.
- The Production Line Lead will motivate production teams to achieve production KPI's within their areas.
If you have proven Mechanical knowledge/understanding and strong organizational skills, personal efficiency, time management skills and the ability to prioritize competing demands - we would love to hear from you!