Technical Writer Cleaning Validation
- Ireland, Midlands (Ireland)
- Permanent
- Commissioning, Qualification and Validation
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
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
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