Line Lead – Shift Rotating Cycle
My client, a global pharmaceutical company, who specialises in developing, registering and manufacturing of both human generic and veterinary pharmaceutical products, seeks to hire a new Line Lead.
Reporting to the Production Supervisor. you will be responsible for overseeing Data Integrity Programmes and Strategy at group level.
This role will suit someone from the pharma/biopharma industry, with experience in pharmaceutical Quality Assurance, who wishes to grow their career in a world-renowned organisation.
This is a permanent position, based on site at their headquarters in East Co. Galway.
Responsibilities
- Meet daily and weekly productions.
- Record and alert any production stoppages to maintenance.
- Produce and pack products in accordance with GMP, FDA, and regulatory requirements.
- Completely filling out all required paperwork, checking work orders before signing off.
- Perform IPC inspections in accordance with company documentation.
- Check that machinery and equipment are up to date, functional, and perform regular automation and process checks.
- Make any necessary modifications to machinery or equipment.
- Clean the equipment and the workspace in compliance with the SOPs.
- Conduct on the job training with process operators to assist with training as needed.
- Assist in the creation of new procedures and the review of current ones.
- Assist with the hiring process.
- Making sure that any performance-related issues are resolved quickly and constructively, and, where necessary, elevating to the Production Supervisor.
- Review of technical documentation, ensuring maintenance of hygiene and housekeeping requirements in the production area.
- Assist with Internal and External Audits and assisting with investigations and deviation closure.
Requirements
- University degree in pharmacy, pharmaceutical science, engineering or a related discipline.
- 4 years’ experience in the pharma/biopharma industry.
- Four years of expertise as a SME running fully automated pharmaceutical production processes and pharmaceutical product lines.
- Excellent practical expertise in coaching and change management best practises.
- A track record of setting up and running pharmaceutical machine line processes for solid doses, liquid dosages or blister packing equipment.
- Excellent understanding of GMP, GDP, FDA, and HPRA regulations is required.
- Drive H&S compliance to make sure that all H&S rules and procedures are followed.
For more information, please contact [email protected]
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