Responsibilities applicable to all roles at Barnard Castle site:
* To work as a flexible and motivated member of the team.
* To follow all Standard Operating Procedures (SOPs) and/or Standards of Work (SW) applicable and in which the individual has been trained.
* To act at all times in compliance with Good Manufacturing Practices (GMP) and to report any quality issues.
* To act in a safe manner, always (in compliance with the Health & Safety at Work Act, and all other relevant legislation) and to use safety reporting systems to highlight potential hazards.
* To remain up to date with all training requirements (both ‘classroom’ courses and computer-based training through the ‘My Learning’ internal platform).
* To take part in Continuous Improvement (CI) activities to highlight improvements to equipment and processes.
* To take part in Root Cause Analysis (RCA) and Corrective and Preventative Action (CAPA) processes.
Job Specific Responsibilities:
* To be multi-skilled and demonstrate a level of specialism in a minimum of the disciplines listed below, employing high standards of Good Laboratory Practice (GLP).
* To be knowledgeable in regulatory requirements associated with their specialism area.
* To be able to work without direct supervision in their area of specialism on the Barnard Castle site or other sites as required.
* To develop methodology for new or modified techniques and prepare written SOPs/Methods.
* To train junior staff in any aspects of their work as specified by the Team Manager.
* Create documentation, methods, procedures, protocols and reports to agreed targets.
* To support investigations/projects within their specialism within the department.
* To participate/represent the department on major site projects.
* To prepare and publish reports/analyze monitoring data as directed by the Team Manager.
* To liaise efficiently and effectively with Production/Quality Assurance (QA) and other corporate groups as required.
Relevant Job Skills:
* Support audit readiness activities.
* To support routine monitoring programmes within their areas of specialism.
* To provide active support to Team Manager during regulatory inspection.
* Demonstrate knowledge in at least one area of Pharmaceutical Microbiology, e.g., Environmental Monitoring, Finished Product Testing (Endotoxin, Sterility or Microbial Limit testing), Sterilisation, Biological Indicators, Microbial Identification, Lab Equipment validation, Method Validation.
* Detailed understanding of the Quality Management Systems and relevant legislation.
* Effective organisation, communication, presentation and influencing skills.
* IT Skills.
Must have a relevant scientific degree
Seniority level
* Associate
Employment type
* Contract
Job function
* Science and Research
Industries
* Pharmaceutical Manufacturing
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