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Serialization and operation compliance officer

Clonmel
PINEWOOD HEALTHCARE
Compliance officer
€40,000 - €60,000 a year
Posted: 2 October
Offer description

KEY RESPONSIBILITES

The Serialization and Operation Compliance Officer will be responsible for the support and administration of Pinewood global serialization systems, focusing on the technical aspects of Serialisation and Track and Trace. The main responsibilities of the Serialization and Operation Compliance Officer are:

Engineering:

* Continuous Improvement: Assist in analysing and improving production processes to enhance efficiency and reduce waste.
* Data Collection and Analysis: Gather and analyse data related to production performance, quality control, and cost management
* Project Support: Support strategic project delivery in the planning, support and execution of projects.
* Quality Assurance: Support implementation and develop quality control procedures (Example SOP/Work instructions) to ensure products and processes meet required standards.
* Support Production Department with Market Complains/ Deviations and CCFs
* Documentation: Prepare technical reports, documentation, and presentations to support project development and implementation
* Collaboration: Work with crossfunctional teams, including production, quality, and supply chain departments, to implement process improvements.
* Support on line project implementation to ensure project is effective and sustainable.

Serialization Support:

* Configure, implement, and maintain serialisation and trackandtrace systems.
* Provide firstline and escalated support for serializationrelated technical issues, diagnose and resolve hardware and software failures in serialization systems.
* Collaborate with IT, production, and engineering teams to resolve system downtimes.
* Complete system validation activities, including IQ, OQ, and PQ documentation
* Analyse production and packaging line processes to optimize serialization workflows.
* Ensure compliance with regulatory requirements (e.g., EU FMD)
* Provide internal support for system users, troubleshooting and resolution of routine issues.
* Assist with the implementation of new systems and upgrades to existing systems.
* Complete validation activities relating to the implementation of new systems or changes to existing systems.
* Support new product introduction projects.
* Managing Serialization database and reviewing packspecs.

SKILLS AND QUALIFICATIONS:

* Education: Qualifications Framework (QQI) Level 7 or above in Engineering/Operation excellence or a related field.
* Analytical Skills: Strong ability to analyse data and identify trends.
* ProblemSolving: Excellent problemsolving skills to develop effective solutions. Apply Six Sigma tools to improve processes, reduce defects, and enhance efficiency.
* Communication: Excellent documentation, communication and interpersonal skills.
* Technical writing: Experience with SOP/Work instructions/Change control documentation, desirable.
* Knowledge of Serialization software (SaTT Platform) is desirable.
* Six Sigma Belt preferable.
* Strong IT skills.

This programme is an opportunity to develop skills and gain experience across multiple departments. This position will be a vital role in supporting the optimization of manufacturing processes and systems, this role is an ideal development opportunity for the right candidate to develop their skill set and career.

Job Type: Full-time

Pay: From €40,000.00 per year

Benefits:

* Additional leave
* Bike to work scheme
* Company pension
* Employee assistance program
* On-site parking
* Sick pay

Ability to commute/relocate:

* Clonmel, Co. Tipperary, CO. Tipperary: reliably commute or plan to relocate before starting work (preferred)

Application question(s):

* Do you hold a qualification Level 7 or above in Engineering/Operation excellence or a related field?
* Do you hold experience with Six Sigma Belt? (If yes, how many years)

Work authorisation:

* Ireland (required)

Work Location: In person

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