This is an excellent opportunity for an experienced QA professional to join a successful and expanding company which offers good long-term career prospects.
The role will support the Technical and Operations Departments with the implementation, adherence and monitoring of efficient processes and systems.
The successful candidate will have previous experience working with ISO 9001 and GMP and an understanding of the regulatory requirements necessary in the production of chemical products.
- Devise, upgrade and establish the company’s quality procedures, standards and specifications in accordance with the principles of ISO 9001 and GMP
- Implement and maintain a document control procedure to enable any changes to be approved, reviewed and updated following management authorisation.
- Apply technical knowledge to ensure adherence to and compliance with established and intended future policies and procedures by working collaboratively with one or more of the following areas: manufacturing, testing, quality systems, research and development, and procurement.
- Provide support in the monitoring and analysing of manufacturing process performance and notify management of potential quality issues that may affect product quality or regulatory compliance.
- Ensure products are manufactured in compliance with company policy and any GMP or Biocidal Product Regulation requirements by reviewing batch records and performing appropriate investigations.
- Provide support to resolving raw material, in – process material, bulk and final product issues.
- Review batch history and process records as needed. Compile and verify all documents associated with the batch.
- Manage day to day activities for the initiation, tracking and closure of working orders / instructions.
- Monitor production processes and gather information for use in continuous improvement of areas of responsibility.
- To work unsupervised to ensure that the business goals are achieved in a timely and efficient manner.
- To assist with the standardised testing of all finished product in an effort to verify reliability.
- To provide assistance for analytical testing which may include sample preparation, measurement and data processing.
- Ensure that an internal audit programme is adopted to verify that the QMS conforms to planned arrangements, QMS arrangements and is effectively implemented and maintained. Ensure that appropriate action is taken when this is not the case.
- To perform scientific investigations regarding the physico-chemical characterisation of necessary product ranges, as required to support applications for marketing authorisations relevant national or international legislation.
- Third level qualification in a relevant scientific discipline or equivalent experience.
- Experience in / knowledge of quality assurance, good manufacturing practices and validation practices / principles.
- An understanding and knowledge of chemical reactions and formulating strategies involved in the creation of chemical products.
- An understanding and knowledge of regulatory requirements with regards to the production of chemical products.
- An understanding and knowledge of plant and process equipment involved in the creation of chemical products.