Lead Manufacturing Operator
- Dublin
- Contract
- Commissioning, Qualification and Validation
Do you want to be part of one of the top 10 best companies to work for in Ireland? We have a superb opportunity for a Lead Manufacturing Operator to join our client, a global pharmaceutical organisation in their new multifunctional facility. This is a truly exciting, €400 million project that will contribute to the manufacturing of life changing treatment, offering an abundance of opportunities to work with and learn about cutting-edge technologies.
Lead Manufacturing Operator Responsibilities:
- Carry out and support operations to achieve assigned duties.
- Deliver shift standard work for a team-based approach to batch progression.
- Complete COMMIT cards to highlight ways of working within our SDWT’s and Hubs and across our site that support our COMMIT culture.
- Conduct sampling/ in-process testing supporting the manufacturing and validation processes.
- Document executed activities necessary to allow proper accountability and traceability of production records, Right First Time (RFT).
- • Author, review, and/or edit procedures and technical documents to ensure the documents are in accordance with cGMP requirements.
- • Provide coaching to the shift teams on the RFT approach to documentation.
- • Ensure that all assigned tasks related to manufacturing documentation support is in accordance with good manufacturing practices.
- Bachelor’s Level 8 degree in Science, Engineering or other Technical Discipline.
- 5 years experience in a GMP environment.
- 3 years experience in Biopharma industry, with direct experience of biologics manufacture.
- Proven record of accomplishments in a regulated industry required
- On-the-floor current Good Manufacturing Practice (cGMP) manufacturing and familiarity with regulatory requirements.
- Proficiency with automated systems such as Manufacturing Execution System (MES - PAS X),
- Systems Applications and Products (SAP), Delta V etc.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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