Supplier Quality Manager
|Job Title:||Supplier Quality Manager|
|Contact Name:||Laurentina Kennedy|
|Job Published:||almost 2 years ago|
The Quality Control Manager will hold responsibility for all QCI activities in support of all aspects of commercial, clinical and development activities at the site.
As the primary QC contact for QCI activities the QC Manager in this role will ensure that quality control support is provided across all business units including QC and non-conforming material/deviated batches. Further, the QC Manager ensures that the QC team provide oversight and direction for all third party facilities which provide key packaging materials to the facility. The QC Manager is accountable for the QC function and must show the competence to drive it forward and the overall management skills to ensure that QC adds to the greater benefit of the facility. In association with the Senior QA Manager the QC Manager will work to meet company goals and objectives, customer requirements and the regulatory obligations as laid down by the FDA, EU and regional Ministries of Health.
Reporting to: Senior QA Manager
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, re-inspections 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
For further information on this QC Manager position please contact Laurentina Kennedy at The RFT Group on 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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