Our Client is a manufacturer of veterinary pharmaceutical and nutritional products for commercial farm livestock and companion animals. The company is Irish owned and was established in 1990.
The plant is an E.U. approved facility and fully complies with cGMP (current Good Manufacturing Practice). For the past 30 years, the company has specialised in the formulation and manufacture of vitamin and trace mineral products in both injectable and oral forms. The company currently has a vacancy for the position of ‘QP/SQE’. This is a senior position with the main responsibilities being:
- Provide back up to existing QP, as required
- Overview cGMP compliance for the Engineering and Production functions
- Provide Technical Expertise to manufacturing processes and assist with future capital investment
- Carry out tasks relating to the management of site change control systems.
- Approve and compile, where appropriate, validation protocols and reports (process, equipment, etc.).
- Oversee and support all validation activities on site as described in the Site Validation Master Plan. This is in conjunction with the Site Engineer.
- Support system qualification and process validation activities.
- Review and approve SOPs/work instructions/forms from other departments on behalf of Quality Assurance Participate in regulatory and customer GMP inspections of the site.
- Perform GMP audits on-site and at vendor facilities as required.
- Regularly maintain and keep health and safety policies up to date
- Raise Health & Safety awareness amongst our management and labour force and implement requirements necessary for our obligations
- Third Level Qualification in a Science/Engineering related subject
- QP Qualified
- Previous experience in an FDA manufacturing environment is desirable
- Technical knowledge of sterile manufacturing processes
- Operational experience of quality systems in a dynamic manufacturing environment
- Knowledge of requirements for cGMP/FDA and EU regulatory requirements
- Full understanding of relevant quality, safety and compliance regulations
- Good communication skills at organisation, team and individual levels
An attractive salary is available for this position. The role is for a 5-day week (8.30am – 4.30pm).