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Job ID: JOB-13640
Quality Assurance Specialist

An amazing opportunity has arisen for an Associate Quality Assurance Specialist to join our client who is a leading name in the pharmaceutical industry. This organisation has worldwide expertise but also a local presence within their specialised field.

Location – Tipperary 

Contract length – 7 months

Hybrid work option available

Key Responsibilities:



• Participate as functional expert in the cross functional team that manages production right first time.

• Review and approve Quality System documentation.

• Ensure that all Laboratory Out of Specification (OOS) and process deviations are documented, assessed and associated CAPA identified. Provide support to deviation investigations and process performance monitoring. Perform trending on deviations raised as required to identify improvement initiatives.

• Provide guidance on quality requirements to maintain validation status, including participation in process/product Risk Assessments.

• Provide detailed knowledge of quality systems in place and ensure that root cause is identified and corrective actions as appropriate are completed.

• Provide feedback on re-occurring issues ensuring continuous improvement to systems/processes.

• Prepare Annual Process and System Reviews.

• Act as lead/team auditor to support the internal GMP walkdown and scheduled audits.

• Creation, review and approval of quality procedures as required.

• Supports the implementation of site or capital projects by defining validation requirements and providing technical assistance and support as a member of the project teams.

• Develops Validation Summary Reports and assist in developing overall Quality plans for major projects.

• Laboratory QA oversight – Support and approve the systems supporting laboratory functions, instrumentation and GLIMS. Provide Quality oversight and approval for laboratory incidents / investigations and documentation.

• This list is not exhaustive – full spec available upon request

Qualifications:



• Degree or post-graduate qualification in Science, Pharmacy or equivalent.

• Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise).

• Knowledge and demonstrated expertise in Lean / Continuous Improvement.

• Experience and knowledge of GMP Requirements for Electronic /paper free operations. • •Experience in any of the following:

•High potency/ Spray drying/Laboratory/API/Oral Solid Dose/Project Management desirable.

For further information on this role in Tipperary please contact Maraleeze Keane on 086 441 0614 or recruit@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval. Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Maraleeze Keane

JOB-13640

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