Technical Support Specialist

Job Overview
The Technical Support Specialist is responsible for providing support for the overall consistent running of the manufacturing and filling areas. This includes leading investigations to identify root cause and appropriate corrective actions to meet production output requirements.

Main Activities/Tasks

• Investigate deviations, working closely with manufacturing staff, 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 ensuring that root cause for deviation has been identified and work with the manufacturing team to develop a CAPA to prevent reoccurrence.
• Liaise with 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 validation of new and existing equipment and processes ensuring they meet GxP standards and that they improve the quality and product output deliverables.
• Raise necessary Change controls to ensure 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 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.

Essential Criteria:

• 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.

Desirable Criteria:

• 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

Duration: Full time, permanent.
Location: Newry

Additional Information:

• This role will be based in a site that produces and handles penicillin, and as such, this role would not be suitable for those that have a penicillin allergy.
• Applicants should be able to provide proof that they have a right to work in the UK at the time of their application. Applicants who are unable to provide this proof will not be considered

Benefits:

• Free Life Assurance
• Company Pension Scheme
• Healthcare cash plan
• 32 days annual leave
• Wedding Leave
• Company Sick Pay
• Employee well-being initiatives
• Employee Assistance Programme
• On-site free parking
• Subsidised Canteen Facilities
• Employee Perks scheme
• Annual Employee raffle
• Employee Recognition scheme
• Career development opportunities