Reporting to the Head of Quality will be responsible for developing, implementing, auditing and maintaining the quality system according to GMP requirements and will have management responsibility for the Quality Assurance, Validation, Quality Control and Stability functions.
- Responsible for the maintenance of the company Quality Management System.
- Initiate appropriate action such that non-conformities relating to the product, process and quality system are prevented.
- Investigate customer complaints and implement corrective action where appropriate.
- Review and approve company quality procedures.
- Initiate, recommend and if possible provide solutions to problems through the designated channels. Verify the implementation of these solutions.
- Control further processing, delivery or installation of non-conforming, product until the deficiency or unsatisfactory condition has been corrected.
- Manage the introduction of new products within the quality management system.
- Assist in new product development by recommending and /or establishing the necessary quality/quality control functions.
- Review and monitor the validation of production processes and equipment qualifications in cooperation with Production and QC Lab Supervisor and Maintenance & Engineering Manager.
- Ensure suggestions for Quality Improvements, problem solving etc. made by members of the Quality Assurance department are discussed with the appropriate personnel and taken on board if feasible.
- Conduct internal audits in areas for which the Quality Manager is not directly responsible.
- Ensure that training records are maintained and a training plan prepared for each member of the Quality Assurance Department.
- Conduct verification of packaging components, labels etc.
- Interview and select personnel for the Quality Department with an input in the recruitment for the other functions within the company.
- Ensure that the need for extra resources is identified and that adequate resources i.e. Equipment and appropriately trained personnel are available such that the department and ultimately the company can meet its contractual requirements and that product quality and conformance are assured.
- Prepares reports and present details on the performance of the company from a quality perspective in cooperation with other managers.
- Preparation and review of Technical Agreements on behalf of Chanelle Pharma
The above is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required.
- Sc. / M.Sc
- HPRA Experience
- 5+ years Management experience, with at least 5 years in pharmaceutical industry incorporating QC and QA experience, production experience would be advantageous.
- Demonstrated ability to work and communicate effectively cross-functionally with at all levels of management.
- Proactive, motivated, analytical and strategic thinker.