Validation Specialist

Validation Specialist

East Midlands

Competitive Salary

Our client is a leading manufacturer of nutritional supplements with extensive facilities located in the East Midlands. Due to continued strong performance they are looking to recruit a permanent Validation Specialist into their Quality Assurance team.

This is a site-based role, and you will participate within the sites Quality Management System by performing and maintaining a programme of validation activities to meet regulatory (MHRA, BRC, GMP etc), company and customer requirements.

Role

Plan, work and self-track against Validation Plans and company projects.

Produce and maintain protocols and reports for at least three of the following areas: critical cleaning procedures, computerised systems, equipment and utilities, processes.

Responsible for interpreting results of validation test work in relation to “Acceptable Criteria” and for appropriate follow up/documentation.

Conduct a range of validation tests with minimal impact on operations.

Maintain the validation status of critical cleaning procedures, computerised systems, equipment, processes and utilities.

Review of analytical data generated by the QC Laboratory, for any non-routine / non-validation activities or projects.

Participate in company audits / inspections and where necessary execute corrective actions.

Timely investigation of NCRs including root cause analysis and risk Classification.

Participate in the maintenance of the Site Validation Master Plan (VMP) ensuring it is up-to-date with current legislation.

Check and approve validation documentation for use in validation activities.

Candidate

Degree in Chemistry or related subject, perhaps also Microbiology.

Experience working in a regulated (GMP, MHRA) manufacturing environment within pharmaceuticals or related sectors.

Knowledge of Validation and/or Quality Assurance requirements in a regulated manufacturing environment, ideally with direct experience in a Quality / Validation role.

Some knowledge or experience of analytical chemistry would be beneficial.

Knowledge of GMP / MHRA requirements and understanding of QMS processes.

Happy working as part of a team and able to collaborate with a range of colleagues.

Excellent written and verbal communication skills.

Competent with IT in particular MS Office applications.