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Quality Assurance Documentation Controller

Posted 9 hours 6 minutes ago by PVH (Tommy Hilfiger/Calvin Klein)

Permanent
Full Time
University and College Jobs
Galway, Galway, Ireland
Job Description
Role & What You Will Be Doing

The Quality Assurance Documentation Controller will be responsible for the day to day management of the site GMP documentation system, acting as administrator of My University training quality system for the Quality team. The role will also assist co ordination of all elements of the Quality System assigned to the Quality Assurance Department.

Every day, we rise to the challenge to make a difference and here's how the Quality Assurance Documentation Controller role will make an impact:

  • Work with the Quality systems owner to coordinate, review, and manage the site control of GMP documents.
  • Support batch documentation issuance and reconciliation for the manufacturing records.
  • Perform a detailed review of document changes prior to final approval.
  • Manage the distribution of new documents and or retrieval of old documents (internally & externally).
  • Coordinate the archiving of quality records.
  • Assist in the preparation, revision and review of quality system records.
  • Manage the My University curricula for the QA team and coordinate training with SME (Subject Matter Expert) for the Quality team.
  • Support the management of material master data.
  • Collate and report the performance metrics within the QA group.
Qualifications

For this role, we're looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

  • Minimum of a Bachelor's degree (or equivalent) in a science related discipline.
  • Experience within a pharmaceutical/medical device company desirable but not essential; a combination of experience and/or education will be considered.
  • Excellent attention to detail, communication (oral & written) and interpersonal skills.
  • Ability to handle multiple tasks in a fast paced environment with strong organisational and time management skills.
  • Experience working with various IT systems and software packages, with strong working knowledge of Microsoft Office (Word, Excel, PowerPoint, etc.).
  • Experience with electronic document management systems is desirable but not essential.
Benefits

At Viatris, we offer competitive salaries, benefits and an inclusive environment:

  • Excellent career progression opportunities
  • Work life balance initiatives
  • Bonus scheme
  • Health insurance
  • Pension
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