Technical Writer Cleaning Validation

1 week ago

Limerick, Limerick, Ireland Quanta part of QCS Staffing Full time
Technical Writer Cleaning Validation - Limerick - 12-Month Contract

Ireland is a hive of activity for the Life Sciences Sector at present with global players setting up new and expanding existing manufacturing facilities all over the Country. An exciting opportunity has arisen to work via Quanta on the client's side for a global Pharmaceutical organisation on a major expansion project based in the picturesque Munster region of Ireland. 

Located just 20 minutes from the nearest international airport, the manufacturing site is workable for those wishing to commute to/from Ireland for a contract position. You will be required on site for 5 days per week Monday – Friday working 45 hours.

Role Summary:
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.  Must Have's:
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) No Biochemistry qualifications are required. If this role is of interest to you, please apply now 

 #LI-CH3

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