LSC have a great contract opportunity for a QA Validation - Technical Writer to join an innovative and rapidly growing Biopharmaceutical company in Limerick.
If you have experience in QA Validation activities and are ready for your next challenge, this could be the perfect project for you!
- Experienced Technical writer
- Experience in Deviation and investigaton 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 necessar
- 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.
- Maintain and update Cleaning/ SIP Validation Plan
- Schedule of Cleaning/ SIP activities with Manufacturing
FIELD OF KNOWLEDGE/EXPERTISE:
- Execution, review & approval of SIP/ CIP and continuing validation protocols and closure
- Extensive experience on writing and approving Deviations
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
To apply, submit your CV via this advert or contact Conor Dolan at LSC on 021-4777329 if you have anymore questions about this QA Validation Contractor - Technical Writer opportunity!