Description
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.
Click Apply now to be considered for the Operations Manager - Quality Management - Dublin role