Our client, a medical device company in ATHLONE are currently looking to recruit a Quality Manager for their growing site.
Summary of the Quality Manager
The Quality Assurance Manager will hold responsibility for all QA/QP activities in support of the process through to product release. The role will provide support to the Director of Quality and Regulatory Affairs in achieving the required goals and objectives; meeting customer requirements and the necessary regulatory requirements as lay down by the FDA and EU regulations.
The QM/QP will develop and maintain a clear compliant quality strategy which will ensure cost-effective and smooth quality and product release processes to include the following responsibilities:
- The Quality Manager is responsible for overall development, implementation, and maintenance of the organisation’s Quality Management System.
- Ensure Quality System processes are lean, compliant, user-friendly and are well understood throughout the organisation
- In collaboration with the Management Team, drive continuous improvement and best practices in our client’s/vendor quality systems
- Manage all quality system and quality control activities within the quality team
- Act in the capacity of a Qualified Person in accordance with Annex 16, EudraLex Volume 4 and Directive 2001/83/EC to support disposition of Products
- Perform final release of the pharmaceutical product
- Manages the batch disposition process to ensure timely release of products
- Review and approval of Change Control requests, Deviations, Complaints and CAPA’s to ensure compliance with all applicable requirements
- Independently initiate and approve SOP updates and creation of new SOPs. Additionally, oversee review of SOPs and associated documentation to ensure review requirements are met
- Conduct supplier audits and contractor audits
- Facilitating, approving and providing inputs into change controls, investigations and non-conformance reviews as required
- Provide Quality support to site projects
- Evaluation of CMO’s Quality Management Systems to ensure the appropriate level and content of reporting, including technical evaluation of quality system reports
- Maintaining and improving quality metrics that incorporate continuous improvement methodologies
- Ability to independently represent the quality function at project meetings and make sound decisions in support of project needs ensuring quality needs are understood and implemented
The Ideal Candidate:
- An MSc in Pharmaceutical Science or similar course recognised by HPRA to permit Qualified Person status as per Article 49 of Directive 2001/83/EC
- At least 5 years’ experience in the Pharma industry within the quality function
- Experience of working within a FDA and EMA regulated environment
- Excellent People Management Skills
- Excellent Organisation, Report Writing, Communication, Problem Solving and Presentation Skills.
- Sound Decision Making and Negotiation capabilities.
- Proven to be self-directed, self-motivated and ability to prioritise competing priorities
- Relationship Building: Establishing excellent working relationships within the qualify team and with all functions within the business.
- Excellent communication and presentations skills, both written and oral. Articulate the quality requirements in a clear, concise and persuasive manner.
- Identify and understand issues, problems and opportunities whilst providing a viable solution.
- Able to work in a fast, dynamic, environment whilst being able to adjust readily to meet unexpected constraints.
For further information on this Quality Manager role in Athlone please contact Orla Crowley on 0860449473/ Talent@hero.ie
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