Technical Support ImmunodiagnosticsWest Midlands Permanent full time position Competitive salary and benefits Are you a life scientist with a working knowledge of immunoassays such as...
Engineering Support Officer- Quality
Location- GrangemouthSalary- Competitive and excellent benefits on offer
SRG are working with a global life science organisation who are going through an exciting period of growth.We are looking for someone to join them as an Engineering Support Officer in a long term role.
This position will have a focus on supporting Quality and QA related functions for the team.
If you have experience in a technical role with a focus on Quality/QA, then this could be the role for you.
- Provide input to support department QMS activities including creation, review and completion of change control, deviations/ investigations, CAPA, Effectiveness Review, Actions and related records.
- Generate, review and update support department Standard Operating Procedures, Operating Instructions, Critical Instrument lists, Periodic Reviews, Risk Assessments and other documentation
- Lead and document support department investigations, ensuring effective CAPA as appropriate.
- Identify and gaps in compliance and ensure all processes are completed within regulatory (cGMP) guidelines
- Participate in qualification and validation activities including generation, review and approval of documentation.
- Ensure all documentation and records are controlled, maintained in archived as appropriate.
- Assist with preparation for internal and external regulatory audits
- Assist with continuous improvement activitiesTrending data and producing reports
- A degree in a related technical discipline or equivalent experience
- Knowledge and experience of Quality Management System Requirements and / or Good Engineering Practice in a pharmaceutical/ medical devices or diagnostic setting
- Experience of updating, creating and approving Quality/ Engineering documentation; e.g. SOPs, Work Instructions, Testing/ Validation Certificates & Reports.
- Experience and knowledge of leading and recording investigations associated with deviations
- Use of investigation, root cause analysis and risk management tools Understanding of change management/ change control principles
If you meet the above criteria and are keen to join a company who are continuing to expand and achieve success in the market then please apply online or get in touch!
Key words: Quality, QA, quality assurance, GMP, GxP, cGMP, CAPA, change control, life science, pharmaceutical, medical device, diagnostics
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.