- Reference: CJ46227
- Job Type: Permanent
- Location: Cork, Cork City, Munster
- Category: Engineering, Technical & Manufacturing
This new role has been created to drive the necessary cultural and operational transformations required for the organisation.
The successful candidate will lead the QA production team of QP’s, QA Specialists and QA analysts, as well as liaising closely with the Production Manager to deliver the customer and business needs in a compliant manner. He will be also responsible for coordination of the certification of finished product batches to the market as required under the EU Directive 2001/83/EC
- Ensure that the batch and its manufacture comply with GDP, GMP, Regulatory Licences and Marketing authorization
- Ensure that all necessary production and quality control documentation has been completed and endorsed by authorized staff
- Maintain oversight of deviations and change controls and ensure any issues which have a regulatory impact are notified to health authorities and mitigated as required
- Pro-actively lead the Production QMR process to ensure that the quality system continues to function effectively and that improvement/remediation actions are taken as required
- Continuous improvement of the quality systems
- Identifying and building inefficiencies as necessary from a systematic and compliance perspective
- Maintain knowledge and understanding of quality oversight for services and operations which are outsourced to CMO’s / contract labs
- Coordinate support for operations in general troubleshooting and problem solving, providing technical direction and guidance to support overall business
- As part of the QA Management Team responsible for driving the Quality goals in support of the overall business objectives
- Maintain up-to-date knowledge of pharmaceutical legislation and industry best practice
- Achieve key project deliverables on time and in the budget and support Ad Hoc projects as and when required.
- Develop and maintain critical relationships with support departments to both develop the role and to enable the growth of the site
Desired Skills and Experience:
- Proven Years’ experience within a regulated environment.
- 3rd level qualification in Science / Engineering discipline
- Eligibility to act as a Qualified Person in line with local and EU directives.
- Good level of knowledge of safety regulations, manufacturing and process automation.
- Excellent interpersonal skills with the ability to work effectively with staff at all levels across multiple functions of the organization.
- Experience in developing strong working relationships across teams and functions.
For a confidential discussion and more information on the role, please contact Eloísa Ruiz on 021 4911066 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
Follow us on LinkedIn and connect with our Recruitment Consultants to discuss the latest jobs, our job searching tips & videos!