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Quality Assurance Manager/Leader

  • Sector: Science & Pharma
  • Contact Email: rory.walsh@collinsmcnicholas.ie
  • Job Ref: 18172

Fantastic Opportunity for a QA Manager in a Cork based expanding Life Sciences Multinational.


The QA Leader/Manager is responsible for managing and providing leadership to the QA Production team of QP's, QA Specialists and QA analysts, as well as liaising closely with the Production Leader in the Cork Site to deliver the customer and business needs in a compliant manner that enhances the direct relationship culture. 


The QA Leader will engage with the relevant support departments and build strong relationships with same.

The QA Leader reports to the Director of Quality Operations.


DUTIES AND RESPONSIBILITIES:

▪ To coordinate all QA duties relating to production batch release and communicate all issues

relating to batch release schedule in a timely manner.

▪ To schedule, manage and deliver the batch release schedule in compliance with Regulatory

requirements and GMP guidelines.

▪ Ensure that all necessary production and quality control documentation has been completed

and endorsed by authorized staff.

▪ Maintain oversight of deviations and change controls within the production platform.

▪ Plan for future requirements of QA Production, including such aspects as procedural

requirements, new technologies, capital planning, personnel recruitment and compliance

requirements.

▪ Proactively 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 in efficiencies as

necessary from a systematic and compliance perspective.

▪ Coordinate support for Production Operations in general, troubleshooting and problem

solving, providing technical direction and guidance to support overall business requirements.

▪ As part of the QA Leadership Team is 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 budget and support Ad Hoc projects

▪ Develop and maintain critical relationships with support departments to both develop the

role and to enable the growth of the site.


LEADERSHIP:

▪ Ability to create and maintain effective interpersonal relationships with all levels of

personnel within all cross functional departments in the organization.

▪ Excellent communication and negotiation skills promoting openness, dialogue and

collaboration

▪ Results-orientated with a strong ability to effectively troubleshoot and problem solve issues

▪ Exceptional planning skills to consistently deliver stretch targets and objectives.

▪ Promote a culture of continuous improvement.


Candidate Requirements:

▪ 5 – 7 Years' experience within a regulated environment.

▪ 3rd level qualification in Science/Engineering discipline.

▪ Self-starter with good motivational, decision making, planning, project management and

communication skills.

▪ Good level of knowledge of safety regulations, sterile manufacture and process automation.

▪ Excellent interpersonal skills with the ability to work effectively with staff at all levels across

multiple functions of the organization.

▪ Eligibility to act as a Qualified Person in line with local and EU directives, an advantage, but

not essential.

Experience in developing strong working relationships across teams and functions.


For a confidential discussion and more information on the role, please contact Rory Walsh.

Rory Walsh

087 1269567