QA Rep Supplier Management

Claran Consultants Ltd; Limerick; On-site; EUR 55,000 - 75,000; Full time

Job summary

Claran Consultants Ltd in Limerick is seeking a QA Rep Supplier Management to join our global pharmaceutical client onsite for an initial 12-month contract. You will provide quality leadership, govern supplier-related activities and ensure GMP compliance across the area of responsibility.

The role requires a background in biotech/chem or engineering with 3+ years' relevant experience, experience with raw materials and consumables in bioprocess/pharma preferred, and ability to manage vendor

Qualifications

• 3+ years in QA or pharma quality role.
• Experience with supplier management and GMP controls.
• Familiarity with regulatory guidelines in pharma.

Responsibilities

• Own, review or approve supplier-related change controls and deviations.
• Ensure GMP compliance and maintain QA documentation and vendor files.
• Support audits and vendor assessments for materials and consumables.

Skills

QA

Supplier management

GMP compliance

Regulatory awareness

Education

Bachelor's or higher in Biotech/Chem/Engineering

Tools

Microsoft Excel

Job description

Job Description

QA Rep Supplier Management a global pharmaceutical company is seeking a QA Rep Supplier Management to join their Limerick team onsite on an initial 12 month contact. Experience with raw materials & consumables in bio processing/pharma preferred.

Main Purpose and Objectives of Position

Provide Quality leadership, direction and governance for the specific area of responsibility. Manage quality-related matters specific to area of responsibility Responsible for approving appropriate quality-related documents. Approval signature confirms that company and GMP requirements have been met. Carry out day to day activities in compliance with site safety policy and procedure. Promote and encourage safe practices and promptly report any safety concerns. Assures consistent implementation of standards across the quality system. Maintenance of all aspects of GMP compliance for the area(s) of responsibility. Establishment, maintenance and management of a control system for the specific Quality System(s)/Program. Interpretation and application of emerging regulatory & GMP guidelines to the specific Quality System(s)/Program

Key Responsibilities

Benchmarking of current and emerging initiatives in the specific Quality System(s)/Program. Own, review or approve change controls (including implementation steps), deviations (including tasks) associated with Supplier Management. Reports & escalates critical quality issues to the appropriate level of quality management for final resolution. Monitoring of GMP compliance, GMP programs & systems by ensuring a regular presence in the area of responsibility. Evaluation, audit and approval of 3 rd party suppliers/contractors as appropriate for the area of responsibility. Contribution to the Quality plan for specific quality system/program initiatives. Maintains the vendor files for service providers, materials and consumables (generation of audit plans and Q agreements, assists in scheduling of local, national and international audits, manage vendor file periodic reviews as per local SOP, ensure all vendor file content is current and appropriately documented, monitor and modify the supplier evaluation process as required). Generate and maintain vendor files for materials (liaise with purchasing to define supply chain, complete risk assessments in conjunction with procurement and MS&T, participate in the new item code process, approval of material and vendor package, re-evaluation of vendors)

Educational Requirements

BSc, MSc, or PhD in Biotech, Chemistry, Engineering or related discipline, with a minimum of 3 years relevant experience TPBN1_IJ