Technical Writer – Cleaning Validation
Industry : BioPharmaceutical
Summary of Role:
- Experienced Technical Writer.
- Experience in Deviation and Investigation writing,
- Experience in Validation specifically CIP/SIP and continuing validation.
- Experience in assessment of CIP/SIP issues during study runs and closeout of deviations.
- Experience in KAYE validator reporting review beneficial.
- Capable of managing a large program, so project management skills would be necessary.
- An understanding of how manufacturing, CIP and SIP Validation equipment works.
- Generate/review/Approval of SIP protocols.
- Generation of Summary Reports and strong quality background essential.
- Experience in continuing validation and generation of assessments for continuing.
- Assessment of impact of issues/ deviations which arise through the assessment generation.
- Ability to work on own initiative.
- Maintain and update Cleaning/ SIP Validation Plan.
- Schedule of Cleaning/ SIP activities with Manufacturing.
- Liaise with numerous departments.
- Shows focus & a consistence approach to the role and tasks.
- Excellent people skills.
- Ensure Training is maintained and current.
- Follow all EHS/Safety SOP/Policies.
- Actively look for Continuous improvements.
Education and Experience
- Experienced in QA Validation activities.
- Execution, review & approval of SIP/ CIP and continuing validation protocols and closure.
- Extensive experience on writing and approving Deviations.
- Technical writing experience has written a number of white papers and site reports.
- Technical writing experience for continuing assessments
- Experience, or some previous exposure to GDP.
- An administrative role with exposure to GDP (preferred).
- Attention to detail.
- No Biochemistry qualifications are required.
Duration: 1 year