Description
Pharmaceutical company based in Athlone is currently seeking a QC Supervisor. Reporting to the QC Laboratory Manager the successful candidate will supervise all aspects of the Quality Control Incoming Materials Function.Key Responsibilities:
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To supervise testing and release of APIs and Excipients required to support both commercial and development projects
- To supervise testing and release of Packaging Materials and Critical Components required to support both commercial and development projects
- To supervise compliance with current Pharmacopeia
- To supervise Analytical Transfer and Suitability of Use for new APIs and Excipients
To lead and manage:
- A group of analysts while ensuring high cGMP and GLP standards are maintained and adherence to schedules and targets to meet regulatory and business requirements.
- Employee relations, change, policy implementation, motivation, performance, discipline, appraisals, target setting, communications, occupational health & safety, training, etc.
- Regulatory compliance through the creation and maintenance of programs for, training, SOPs and validation. Preparation of documentation for audits carried out by internal auditors and Regulatory bodies. Follow up on the close out of actions/ recommendations identified from both internal and external audits
- Change in the IM group effectively by utilising available resources in an efficient manner
Requirements:
- Third level qualification (BSc or higher) in Science Related Discipline with desired 6years experience in a pharmaceutical environment.
- Previous Supervisory Experience would be desirable.
- Experience of FDA/IMB regulated site.
- Excellent knowledge of incoming material laboratory testing practices, validation of methods and cGMP applicable to a pharmaceutical environment.
- Logical troubleshooting and problem solving skills.
- Excellent written and oral communication skills.
- Proven track record in your current role is essential.
- Experience in lean lab concepts would be desirable.
- Responds positively to changing circumstances and priorities.
If you are interested in the role and company please apply below with an up to date CV or give me a call for me Anna Mooney for more information .