- Reference: CJ43276x
- Job Type: Permanent
- Location: Cork, Cork city, Munster
- Category: Production
The purpose of this role is to embed RCA/CAPA processes to achieve a transformational reduction in deviations and safety incidents and to provide real time on the floor Quality support to the operations teams.
Breadth/ Scope of Accountability:
Scope of Responsibility (primary deliverables expected of the role)
- Providing hands-on support to production that that drives culture change, i.e. strengthening the site continuous improvement culture and intolerance for deviations from operators through to the Site Leadership Team.
- Coaching and mentoring site staff to drive alignment of site processes and procedures with QMS (e.g. GQMP 1007, 1000a and 6007A)
- Working with other site teams, e.g. OE, GPS, Quality Operations and Technical to improve the effectiveness of site RCA/CAPA processes and progress culture change.
- Facilitate, coach and mentor teams and individuals to build site capability in the RCA and CAPA processes.
- Liaising with other sites and Central Quality with the interpretation, implementation and ongoing improvement of the RCA/CAPA analysis tools and processes.
- Trend analysis of Deviations to identify priority deviations for elimination (target “big Wins”) and drive a transformational reduction in site incidents and deviations
- Assisting the site to move to a proactive approach of incident prevention from a reactive approach of incident assessment and management
- Good understanding of Gemba with a Purpose and the ability to perform, train, and coach this tool
- Completion and coaching of self inspections assuring repeat issues are prevented
- Drive inspection readiness to ensure the site is ‘audit ready every day’
- On the floor support of Operations staff by Quality organization
- To deputize for the OQ Shift Team Leader as required.
Impact of role on business objectives:
- Ensure there is an effective problem solving system in place to prevent recurrence of issues and therefore reduce waste.
- Be the focal point of problem solving within the Value Streams when the situation demands it to ensure on-time resolution of issues to support batch release.
- Understand all Quality systems and ensure that product is made to appropriate GMP standards.
Environmental Health & Safety (EHS) Responsibilities:
Scope of Responsibilities
- Perform duties in a compliant manner and behave in accordance with site SOP’s, EHS standards and guidelines and relevant legal requirements.
- Read and understand Standard Operation Procedures applicable to role.
- Report all accidents, incidents and any EHS issues using the appropriate process /system to your line manager or, if required, the Occupational Health Advisor.
- Maintain work area in an inspection ready state and clean as you go to maintain good safe housekeeping standards.
- Be aware of the impact of your job activities on EHS issues.
Scope of Responsibilities
- Perform duties in a compliant manner and behave in accordance with our Quality Management System requirements
- Participate fully in our site’s quality initiatives and ensure that all relevant quality standards are adhered to.
- Assess/investigate the data on products failing to meet requisite standards and reject or rework as appropriate.
- Influence Quality Improvement (QI) programmes in conjunction with the appropriate Business Unit and technical departments that will reduce rejects and customer complaints. Lead QI activities within Operational Quality.
- Approve and monitor all quality-related systems, procedures and documentation utilized within own area and aligned Business Unit.
- Ensure that any changes have been appropriately validated and documented using the company recognized systems of approval.
- Ensure that the Operational Quality Manager and other Business Unit Management (as applicable) are notified of any trends/changes or deviations from GMP, which may have significant effect on product quality.
- Maintain GMP standards where appropriate.
- Read and understand relevant Standard Operating Procedures and Global Quality applicable to role.
- Attend training and complete assessments as required.
- Ability to communicate with a wide variety of people at all levels both within the sites and externally through appropriate skills: – Verbal / written, Negotiation, Report writing, presentation, Empathy / affiliation and listening.
People Management Responsibilities
Scope of Responsibility
- Excellent communication/interpersonal skills with a strong affiliation with customer support.
- Assist all Quality and Manufacturing functions in preparation for, and during external agency audits and internal audits
- Ability to think strategically and use sound judgment.
- A champion of change to improve systems and processes.
- Play a key role during investigations into significant incidents that have resulted in non-conforming products or compliance failures.
- Demonstrated ability to effectively plan work and to manage projects.
- Demonstrated ability to problem solve and lead 6 step root cause analysis
Third Level Science based certificate or 5+ years experience working in a similar role.
Third level science-based diploma or higher degree.
2 yrs experience in a pharmaceutical/ healthcare company.
Understanding of appropriate directives, standards, policies and guidelines and ability to implement appropriately,
• Directive 2001/83/EC
For a confidential discussion and more information on the role, please contact Emer O’ Callaghan on 021 4911061 or email firstname.lastname@example.org
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
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