QA validation Technical writer- Contract

QA Validation Technical Writer
QA validation Technical writer- Contract
QPTech_IT_15042020

Recruiters Comments: Our client, a Biotech multinational based in Limerick and an outstanding employer is currently looking for two QA VALIDATION TECHNICAL WRITER to join their team, on the Contract Basis.
One Technical writer will be working on CTU/Laboratory Equipment validation protocols and another will be working on SIP/ CIP validation protocols.

Job Description:

Job Description of QA validation Technical writer- CTU/Laboratory Equipment

  • Experienced Technical writer,
  • Experience in Deviation and investigation writing and data review
  • Experience in Validation specifically CTU/Laboratory Equipment validation or QA background
  • Experience in assessment of validation issues during thermal mapping runs and closeout of deviations
  • Capable of managing a large program, so project management skills would be necessary,
  • An understanding of how CTU and Equipment Validation equipment works
  • Generate/review/Approval of CTU/Equipment protocols
  • Generation of Summary Reports and strong quality background essential
  • Ability to work on own initiative
  • Experience in continuing validation and generation of assessments for continuing
  • 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/GMP
  • Actively look for Continuous improvements

Role:

Job Description of QA validation Technical writer- SIP CIP

  • 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

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Salary: Attractive Daily Rate
Recruitment Contact

Contact: Vandana Sharma

Telephone: 061209511

Email: hr@qptech.ie

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