QA Associate

R.T. Lane Recruitment are currently recruiting for a QA Associate – Documentation Specialist to work with a Pharmaceutical Company in Cork.

This is an 11-month contract with strong potential for extension.

**Please note that candidates must hold the correct working visa for Ireland as my client cannot offer visa assistance and must be already residing in Ireland**

** Please note due to a high volume of applicants you will only be contacted if

suitable for the position. **

The Contractor will provide documentation (creating, formatting, tracking of SOPs, Work Instructions etc in the MSD Electronic Document Management Systems) support to the Vaccines IPT team.

What skills you will need:

To excel in this role, you must have:

• • 1-5 years’ experience as a documentation specialist or equivalent in a pharmaceutical or a highly regulated environment.
  • Experience in maintaining and updating excel schedules and trackers for small projects.
  • Advanced PC skills such as Excel, Word, PowerPoint.
  • Stakeholder management of multi decision makers, colleagues, peers, and cross functional teams.
  • Knowledge and experience of GMP and GDP in a pharmaceutical environment.
  • Qualification in a biological science subject.

Responsibilities:

1. Creating, editing, and formatting of SOPs, Work Instructions, and other documents on the MSD EDMS (Veeva Vault) from material supplied by the Vaccine IPT SMEs.
2. Liaison with key stakeholders e.g., Quality, Change Control, SMEs etc. to ensure compliance, correctness, content, and delivery.
3. Provides to the site knowledge and experience in Quality Documentation Systems.
4. Responsible for use of the Site Documentation System including Issuance, reconciliation, storage, archiving and retrieval of cGMP documentation to support the manufacture & testing of our products.
5. Uses knowledge to improve Quality Documentation Systems, solve problems, provide continuous improvement, and execute tasks.
6. Part-take in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT
7. Ensure compliance with site EHS policy, cGMP and other business regulations and support Technical IPT input to risk assessments, audits, regulatory inspections, and incident investigations.

For more information or a full Job Description please contact – Michelle Power, R.T. Lane Recruitment on 022 46969, 087 032 8195 or email michelle@rtlanerecruitment.ie