Overview
Perform all tasks during the production process, managing production equipment and verifying the quality of the manufactured product according to the manufacturing guide and cleaning procedures, SOPs, GMPs, and guidelines of the superior. This is to take control of all material produced, check that the consignment complies with the data specified in the guide, and to continue production with another production batch.
Responsibilities
- Operate machines and production equipment safely and in accordance with instructions.
- Reset and supply the machines constantly to avoid running out of materials during the manufacturing process and check that the product is in perfect condition throughout.
- Monitor the quality of the output to identify, discard, or re-manufacture faulty products according to quality area clearance or instructions.
- Check machine controls and prepare samples to attach to the guide and regulatory folders, notifying control for the last verification.
- Ensure the amount of product per container, filling all the rules and controls specified in the production guidance to maintain control of all produced material.
- Maintain accurate daily production records for manufacturing performance analysis.
- Comply with procedures relating to behavior in rooms to ensure aseptic conditions of rooms and equipment.
- Solve any problems the machine may have or alert the shift team leader to advise the mechanics.
- Clean and disinfect rooms and equipment, ensuring no remains from the previous batch are left in the machines and notify quality control for clearance.
- Train new hires in the specific activities and functions of the position in which you are an expert.
Qualifications
- Education: Vocational training related to the job.
- Languages: Fluent Spanish is a must; intermediate English is a plus.
- Experience: +1 years of experience in a similar position in the pharma industry. Injectables experience is a plus.
- Specific Knowledge:
- Travels: Not required.
- Personal skills: Ability to work both in a team and autonomously, dynamism, and proactivity.
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