Job Title: Validation Specialist
">
We are seeking a skilled Validation Specialist to join our team. In this role, you will be responsible for ensuring the on-going validation and compliance of existing and new equipment, systems and processes.
">
Key Responsibilities:
">
">
* Designing, executing and reporting on PV/Process Performance Qualifications;
">
* Designing, executing and reporting on validation studies for equipment, systems and processes;
">
* Ensuring validation studies are managed in conjunction with all required standards and legal requirements (Health & Safety, cGMP, construction, environmental etc.);
">
* Providing technical interpretation and guidance of current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation and dehydrogenation;
">
* Ensuring that the validation status of equipment and systems are compliant with cGMP at all times;
">
* Maintaining validation documentation through the validation lifecycle;
">
* Participation in external regulatory inspections;
">
* Support Site Change Control process.
">
">
Requirements:
">
">
* Degree in Science (Chemistry, Microbiology or Pharmacy preferred) or Engineering Chemical/Mech/Elec;
">
* 3-5 years experience working in a healthcare manufacturing environment ideally part of which would be in the pharmaceutical sector;
">
* Capable of troubleshooting validation issues associated with projects, process development etc.;
">
* Competent technical knowledge of pharmaceutical plants;
">
* Previous validation/product development experience would be highly advantageous for the role;
">
* Knowledge of Process Validation regulations, current process validation and technical transfer industry practices, and experience of interpretation and application of guidelines and regulations;
">
* Knowledge of requirements for GAMP, ISPE Baseline guides;
">
* Knowledge of steam and dry heat validation publications such as AAMI/ANSI, PDA and ISO guidelines;
">
* Full understanding of relevant quality and compliance regulations;
">
* Able to execute projects to plan;
">
* Good knowledge of quality management systems;
">
* Ability to use MS Project and SPC packages an advantage;
">
* Understands KPIs for the site.
">
">
Benefits:
">
This is an excellent opportunity for a motivated and experienced professional to join our team and contribute to the success of our organisation.
">
How to Apply:
">
To apply for this role, please submit your resume and cover letter.
"] ,