Description
Role Requirements:- Good knowledge of GAMP, Delta V and 21 CFR part 11.
- Complete validation plans, FMEAs, validation protocols, validation reports, control plans and test method validations.
- Champion the validation system including maintenance and continual improvement of the validation process in line with regulations and industry best practise.
- Effective and efficient execution of validation and other projects.
- Achieve key project deliverables on time and within budget.
- Champion structured approach to problem solving within the organisation using cross-functional teams and six - sigma methodology.
- Lead and or participate in CAPA and other cross functional improvement teams to drive manufacturing quality improvements.
- Investigate, trouble shoot, disposition and report on validation failures, system failures, non conforming products and other product defects.
- Champion a structured approach to problem solving within process improvement teams.
Person Specification:
- A primary degree in engineering or equivalent.
- A minimum of 2 years pharmaceutical experience.
- Self starter with good inter-personal skills.
- Ability to multi-task is essential. S/he should have strong analytical communication, organisational and influencing skills.
- Previous cleanroom, equipment and process validation experience.