- Reference: GY43475AO
- Job Type: Permanent
- Location: Galway, Mayo
- Category: Science, Pharmaceutical & Food
This is a list of Core Duties and must not be taken as a definitive list. You may be asked from time to time to undertake other duties, either in or out of your area of responsibility
- Provide guidance to direct reports to ensure activities are completed as per schedule and in a GMP compliant manner. Evaluate team’s abilities and developmental needs
- Manage and motivate team members through effective communication and effectively assign responsibility and resources to achieve required goals.
- Hold performance meetings according to company policy.
- Maintain capacity as per business needs including recruitment & management of staff.
- Coach and develop team members to support the Company’s succession planning.
- Maintain strong relationships with management and colleagues in the business units and the quality function, direct reports and customers. Articulate the necessary quality requirements in a clear, concise and persuasive manner.
- To agree with the Senior QA Manager the delivery of the company quality plan and global regulatory requirements for the QC department
- Assess quality implications of new regulatory guidance and implement necessary changes for area of responsibility.
- Manage QC requirements for process changes & new product introductions
- Ensure effective recording, analysis and reporting of QC KPIs ensuring issues impacting quality performance are addressed and drive continuous improvement.
- Demonstrate active support and involvement in successful progress of compliance initiatives to enhance the site quality program.
- Represent the company in Ministries of Health inspections as deemed necessary
- Provide quality control and Supplier quality input for all activities across the business units, including, but not limited to direction on non-conforming material/deviated batches, and packaging activities.
- Prepare and deliver the annual QC budget. Manage the ongoing budget effectively ensuring cost reduction/ efficiency initiatives associated with QC activities are pursued.
- Foster an environment of continuous improvements for the QC area by identifying and implementing efficiencies and quality improvements.
- Provide direction to the QC personnel across all business units ensuring activities are undertaken in a compliant manner.
- Support all process changes and validation projects where QC services are required.
- Co-ordinate QMS Management for area of responsibility
- CORAL: Review and approval of assigned documentation & component drawings.
- ECR approvals in PaxPro
- Process non-conforming documentation including On Holds, reinspections and AQLs.
- Attend all meetings as required or arrange an appropriate deputy. For example:
- Departmental/ANDON Board/APEX/Project Meetings
Education and Experience/Knowledge:
- Proven track record in a quality discipline in the Pharma/Medical Device environment.
- Third level Science qualification
- 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 management 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.
- Culture fit: Have a people centred approach to their management style whilst upholding the values and ethos
- Undertake any training or travel that the role may require, including the completion of quality inspections of third party contract facilities as required
For a confidential discussion and more information on the role/company please contact Amy O’Neill on 091-706718 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
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