Operations Manager - Quality Management

at  Gibbs Hybrid

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.

• 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