Technical Support Specialist

The Technical Support Specialist is responsible for all aspects of manufacturing, providing support for the overall consistent running of the manufacturing and filling areas. This support will include leading investigations to identify root cause and appropriate corrective actions and therefore meeting production output needs of the company.

Main Activities/Tasks

• Investigate deviations, liaising with and working closely with manufacturing staff in production, recommend robust CAPA’s to prevent reoccurrence and ensure timely disposition of all material in QT that is relevant to assigned area.
• Assist in the investigation of deviations for area and ensure that root cause for deviation has been identified and work with the manufacturing team to develop a CAPA to prevent reoccurrence.
• Liaise with the production team to generate documentation (Validation protocols, reports, PCRS) for area and work with cross functional teams to ensure documentation reflects manufacturing process.
• Assist in the validation of new and existing equipment and processes ensuring they meet all GxP standards and that they improve the quality and product output deliverables.
• Raise Change controls when necessary to ensure where appropriate no impact on production schedule. Liaise with other departments to ensure change control meets necessary requirements and support closure of existing change controls in a timely manner.
• Support the production team in their work with other departments in Compliance Excellence initiatives to ensure area is fully compliant with all GMP and customer requirements.
• Support effective development and training of staff through SOP updates and change controls.
• Maintain a robust database of production related consumables ensuring availability to meet production requirements and that they meet cGMP standards
• Flexibility, some areas of operation are continuous and will require occasional out of hours support.

• Degree qualified (or equivalent) OR a minimum of three years of relevant experience in a regulated industry.
• Highly motivated to achieve targets on time.
• Very good problem-solving skills and ability to easily interpret instructions.
• Independent and highly motivated with strong communication skills both written and oral, prepared to work in a cross-functional collaborative environment to deliver results.
• Demonstrate Skills in administration (Microsoft Word, Excel, etc.), coordination and project support., * Experience of working in a regulated environment (i.e., Pharmaceuticals, Healthcare, food sectors or demonstrate transferrable skills from current role to meet experience required to work in a regulated environment).
• Previous Aseptic Sterile manufacturing experience or demonstrate relevant knowledge of the requirements for working in a cleanroom facility both sterile manufacturing and/or GMP non-sterile manufacturing.
• Experience in Lean/Six Sigma methodology