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Site Quality Manager

Ref: 76252

  • 80,000-87,000
  • 15 Dec 2021
  • Waterford
  • Permanent

Site Quality Manager

About the Company

This international Life Sciences company has been expanding it's site in Waterford for the last 2 years led by increasing demand for it's products. They are now seeking an experienced Quality Manager to lead the Quality function at the site.

About the Position

In this role you will lead the high performing Quality team at the site, ensuring the QMS is compliant and that the site is Audit ready at all times. You will also drive and oversee continuous improvement projects in the Quality space.

Key Responsibilities

  • Establishes the duties and responsibilities of Quality department staff and prepares concise job descriptions.
  • Gives counselling and training as appropriate to ensure that existing employees are worthy of promotion when opportunities arise.
  • Act as a coach and mentor to reporting staff and colleagues.
  • Host the site Quality Management Review in line with agreed frequency, ensure action follow-up and timely close out.
  • Defines audit plans for QA-process and internal audits for the plant, ensure schedule compliance and sufficiently trained auditors are available to perform audit.
  • Responsibility for the data gathering and reporting of Annual Product Reviews
  • Identify and drive quality improvement projects to reduce the number of CAPAs arising within the business
  • Ensure capability of hosting of third party audits, ensuring general audit readiness throughout the business.
  • Responsible for the quality data trending eg CAPA, OOS, Deviations, Customer Complaints and Change Requests and driving quality improvements across the site.
  • Interface with customers to ensure concerns/complaints are communicated and effective corrective and preventive actions are implemented in a timely manner.
  • GMP Training preparation and execution as required including GMP Induction Program, Annual GMP Training (site and supplier) and Training in QMS processes as required.
  • Prepares monthly QA-statistics and reports to Senior Director Quality Ops
  • Final Batch release decision, including responsibility for the execution and final disposition of  IPC and incoming testing as well as trending of this data.
  • Responsibility to accept or reject suspect raw material and auxiliary material.
  • Audits suppliers and supports issues of delivery specifications for raw materials and auxiliary materials in co-operation with Quality Systems.    Responsibility for the approval of change controls, qualification of new equipment and/or validation of new processes.

Experience/Requirements

  • Master diploma with scientific background
  • Minimum 4 years of experience in Quality Leadership role
  • cGMP, ISO 9001, ISO 15378
  • Green belt training 
  • Support and contribute in Lean Sigma programs and activities towards delivery of the set target

Remuneration Package

A strong salary and package is on offer for the right candidate.
Contact

For more information on the role or any other Engineering or Life Sciences roles call Nigel on 087 3618142 or email me or click the apply button below.

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