- Reference: CJ44714y
- Job Type: Contract
- Location: Munster, Waterford
- Category: Science, Pharmaceutical & Food
- Process owner for L1 and L2 audit programme, and successful implementation of same on site.
- Support Management Review/Quality Council.
- Support Quality Audits Level 1, 2, 3 and 4 Inspection Readiness activity
- Support CAPA Process and Quality Alert Process
- Quality metrics
- Familiar with Regulations (Medicinal and Medical Device)
- Site Recall/PIRC procedure
- Internal Halal Auditor
- Supports site TIP projects as required
- Continuous improvement in Quality team processes
- Procedures review and approval
- Quality Representative support to other departments
- QMS Implementation support
- Risk Management (support identified risks as required)
Environmental Health & Safety (EHS) Responsibilities
- Perform duties in a compliant manner and behave in accordance with site SOP’s, company 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
- Ensure all engineering changes made have safety considerations and best practices as core attributes.
- Ensure basis of safety files are available and up to date for processes.
- 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
- Maintain GMP standards where appropriate to your role
- Read and understand relevant Standard Operating Procedures and Global Quality applicable to role
- Management Policies relevant to your job role
- Attend training and complete assessments as required
- Ensure Quality and GMP are at the forefront of changes proposed
- Awareness of appropriate Directives, Standards, Quality Managements Systems related to the manufacture of Medical Device’s for required markets; As below
i. Medical Device guidelines
ii. QMS company Policies and Procedures
iii. Pharmaceutical Affairs Law Japan
iv. EU GMP guidelines
- Understanding of and ability to implement GPS initiatives
- 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
- Demonstrated ability to problem solve
- Demonstrated ability to effectively plan work and to manage projects
- Ensure Halal requirements are met in accordance with General Guidelines of Halal Assurance System LPPOM MUI for applicable Medical Device products / markets.
Qualifications & Experience
- Third level science-based degree is preferable.
- 2 years’ experience in pharmaceutical / healthcare industry preferably in a similar role.
- Understanding of and ability to implement continuous improvement projects.
- 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.
- Familiarization with products manufactured in all Value Streams.
- Thorough knowledge of site quality systems.
- Demonstrated ability to problem solve.
- Demonstrated ability to effectively plan work and to manage projects.
- Expected level of application of Knowledge Understanding of Quality Managements Systems related to the manufacture of Medical Device and Medicinal products for required markets.
For a confidential discussion and more information on the role, please contact Rory Walsh on 021 4911063 or email email@example.com
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