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Our client, a pharma company in Mayo is currently looking to recruit an QA Manager/QP for their site.
The Quality Manager will hold responsibility for QA activities in support of the process through the Product Release Function. The role will provide support to the QA/QP Associate Director in addition to the Business Unit Leader in achieving the required goals and objectives; meeting customer requirements and the necessary regulatory requirements as lay down by the FDA, EU and regional Ministries of Health as relevant. The Quality Manager will assist the Associate Director in the management of key quality system elements including:
- 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
- Manages the batch disposition process to ensure timely release of products
- Ensures the batch disposition process maintains compliance with site practices and regulatory requirements
- Support the Non Conformance/ CAPA program
- Support the Change Management program in the Business Unit
- Be a SME for quality records and quality systems, ensuring consistency of records
- Promote technical writing and quality awareness
- Provide Quality support to site projects
- Support the Self-Inspection program
- Inspection Management (internal site preparation, pre-audit MOH requests, Response/ report compilation & issuance, Post audit commitment management)
- Represent quality at daily and weekly cross functional meetings
- Support the site quality plan and ensure plan execution
- Coordinate compliance initiatives
- Support the Site Quality Risk Management Program
The QA Manager will have the authority to hire, promote and manage the performance of the product review department. The total staff to be supervised included three direct reports.
- Maintain strong relationships with management and colleagues in the business units, support functions and the quality site and global functions.
- Articulate the necessary quality requirements in a clear, concise and persuasive manner
- • Manage and develop the Product Review Department %
- Quality project oversight
- Identify and support the implementation of the action plans to eliminate re occurring issues within the Business Unit.
- Identify areas to continuously enhance the performance of the Business Unit and support the implementation of key initiatives
- Develop and follow Leader’s standard work.
- OPEX Tier meetings
- Drive Quality Culture and Compliance improvement initiatives
- Annual Product Review
- ECR/ECO Approval through PAM
- RCPS Focus on Reduction in Repeat and Human Error deviations
- Co-Ordination of Business Unit Quality Defect Reports
- Focus Site Quality and Plant of the Year (POY) metric achievement
- QMS records Review and Approval
- Validation documents, Project documents, Risk assessments, Master Records, SOP Review and Approval
- Representing the Company at client and regulatory facing meetings
- QP support regarding batch certification and approval of CofAs
- Attend all routine meetings as required.
- 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
- Co-ordinate the completion of process improvements initiatives in conjunction with the Business Unit Managers.
- Support and ensure the Quality Management System is maintained to a high standard.
- Administer LMS/CORAL.
Job Qualifications (Minimum Requirements):
Education and Experience
- Bachelors degree in scientific discipline
- Education requirements for Qualified Person eligibility
- Minimum 5 years of relevant work experience in pharmaceutical or related industry
- Experience in aseptic manufacturing and sterilisation processes is desirable
Essential Skills, Experience
- Clear understanding of working within a regulated environment
- Excellent communication skills
- Ability to use sound judgment to make effective decisions within appropriate timeframes
- Proven to be self-directed, self-motivated and ability to prioritise competing priorities
- Relationship Building: Establishing excellent working relationships with all functions within the business unit and QA team.
- Communication: excellent communication and presentations skills, both written and oral. Articulate the quality requirements in a clear, concise and persuasive manner.
- Planning & Organising: excellent analytical skills. Ability to plan and schedule.
- Decision Making: identify and understand issues, problems and opportunities whilst providing a viable solution.
- Adaptability; Able to work in a fast, dynamic, environment whilst being able to adjust readily to meet unexpected constraints.
- Passion for results: - Drive, high energy, maturity, and ability to work under pressure and deliver results; get things done (an action-oriented approach); overcome obstacles.
- Receptivity to feedback - Receptive to the ideas of others and welcome and accept constructive feedback, display humility where appropriate.
- Have a people centred approach to their work whilst upholding the values and ethos
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