Job Description

  • Employment Type: Contract
  • Job Location: Dublin
  • Date Posted: Posted 4 months ago
  • This position has been filled
  • Salary:Competitive

⦁ JobTitle:  QC Analyst (Stability) 28961A

⦁ About Company:  Our client based in Dun Laoghaire is seeking a QC Analyst (Stability) to join its expanding team

⦁ Duration of Role: 12 months

⦁ Summary Objective:   This role will support QC, NPI and manufacturing operations, as such some extended hours, out of hours and weekend work flexibility may be necessary as required

⦁ Job Duties:

• Support Stability Programme on site and frequent collaboration with global Stability Product Representatives (SPR) or Product Quality Leads (PQL) regarding all stability programme matters.

• Perform routine sample management tasks as per procedures.

• With a high degree of technical flexibility, work across diverse areas within QC

• Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of tasks.

• Troubleshoot, solve problems and communicate with stakeholders.

• Initiate and/or implement changes in controlled documents.

• Participate in audits, initiatives, and projects that may be departmental or organizational in scope.

• Introduce new techniques/ Processes to the area, where appropriate.

• Evaluate sample management practices for compliance and operational excellence improvement on a continuous basis.

• May provide technical guidance. May contribute to regulatory filings.

• May represent the department/organization on various teams.

• May interact with outside resources.

• Perform general housekeeping in all sample management areas.

• Support all NPI activities with QC

Requirements
SKILLS AND REQUIREMENTS

• Bachelor’s degree in a Science related field is required.

• 3+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical industry,

• Would be advantageous if the candidate has a minimum of 2 years of specific sample management/ stability Programme management experience.

• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.

Primary Responsibilities, Accountabilities and Decisions Rights

• Sample management activities across the site

• Create/own and approve protocols, sample plans, SOP and documentation

• Responsible for SAP and LIMS functions/ transactions within the sample management remit

• Out of hours responder for sample management equipment (fridges /freezers / incubators)

• Responsible for their own training and safety compliance.

• Sample shipments and temperature monitoring activities.

• LIMS data coordination of commercial and import batches.

• Management of the Inventory of Reference Standards and assay controls, training and verification samples

• QC Representative for NPI activities and routine Product meetings

Benefits
Benefits of working with Independent Solutions

> Excellent Team of Colleagues

> Access to high-value projects

> Excellent Technical Project Managers

> Excellent pay & conditions

 

Independent Solutions are Approved Suppliers for Multinational Pharma Biotech, Medical Device, clients with locations based here in Ireland.

At Independent Solutions, we will not require you to become an employee of Independent Solutions, we will facilitate and support you to become an independent contractor, thereby reaping the maximum rewards from your contract role.

We work in the area, we know the business, we are not a recruitment agency!

We continue to partner and grow our client base and thereby ensure that we have continuous supply of excellent roles

Yes, of course we benefit from having YOU with US, but we can assure YOU that YOU too will benefit …