Job Application

Operations Manager - Quality Management - Dublin

Gibbs Hybrid is looking for a proficient Operations Manager to be responsible for supporting the maintenance of Quality Management Systems. These activities include change control, non-conformance investigation, supporting internal/corporate and health authority inspections, supply chain projects, compilation of metrics and document management. You will be required onsite 50% of the time.

* Manage all documents in accordance with records management procedures and data integrity requirements
* Serve as the Local Process Owner in the execution of QMS activities, compliance initiatives, best practices, and industry standards per implementation strategy
* Monitor deviations, internal and external change controls
* Develop responses to internal audits and ensure appropriate implementation of corrective actions as required
* Support and participate in local initiatives or projects to increase compliance and reduce costs/non-conformance.
* To lead technical or risk assessment exercises where needed including contracted activities which may impact on GDP.
* To execute ad-hoc reviews of processes and procedures and provide support in collaborating with Compliance Excellence on executing the self-inspections per defined intervals) and implement corrective actions as necessary.

Essential:

* Operations management
* Quality management systems/quality controls experience
* Excellent interpersonal skills
* Ability to operate as part of a team is critical.
* Innovative/Adaptable and flexible
* Excellent communication skills both written and verbal
* Attention to detail/Results and performance driven
* High customer orientation, excellent interpersonal, communication and teamwork skills
* Ability to build trustful relationships, engage and influence stakeholders at all levels, including market and GPS leadership
* Excellent analytical, organizational, and problem-solving skills
* Previous Medical or Pharmaceutical industry experience very helpful
* Formal certified GDP Training on Good Distribution Practice of Medicinal Products for Human Use
* Up to date knowledge of relevant pharmaceutical legislation and GDP.
* Ability to apply GDP regulations and international guidelines to all aspects of the position.
* Demonstrated knowledge and application of industry regulations as they apply to quality, including those of HPRA, EMEA, FDA and other authorities.

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