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Experienced aseptic manufacturing specialist

Dublin
beBeeManufacturing
Manufacturing
Posted: 7 July
Offer description

Job Opportunity

We are seeking a highly skilled Manufacturing Manager to join our team. The successful candidate will be responsible for overseeing the manufacturing process, ensuring quality and efficiency.

This is a contract role, offering an hourly rate of €50 - €55 per hour. The minimum contract duration is 18 months, with the possibility of extension.

The role involves working on-site, with a maximum of two days per week. However, the majority of work will be done remotely. Travel may be required occasionally, covering short trips to various locations in Europe.

* Responsibilities:
* Managing and executing total quality management systems

* Executing nonconformance, CAPA, SICAR, Change Control, and metrics oversight responsibilities

* Acting as category owner for all quality records and procedures

* Processing, investigating, and acting as first responders to deviations

* Addressing and expediting product deviation under the company's quality management system procedures

* Maintaining unified product defect investigation operating procedures

* Providing technical expertise to optimize deviations management, corrective, and preventive actions effectiveness, and prevent reoccurring events

* Maintaining and monitoring systems to ensure that all deviations received are appropriately investigated and concluded per the company's quality standards and procedures


Requirements

To be considered for this role, you must have:

* Qualifications:
* Bachelor's degree and 8 years of Quality and/or Manufacturing experience

* 6+ years related work experience (manufacturing, process development, or quality assurance) in Biotech or pharmaceutical industry with demonstrated experience in compliance, problem solving, advance root cause analysis, critical thinking, project management, and quality systems


Preferred Skills

Prior experience in aseptic filling or tech transfer drug packaging is desirable but not essential.


Contract Details

This is a contract role with a minimum duration of 18 months. The hourly rate is €50 - €55 per hour. Travel may be required occasionally.

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