QA Manager

Competitive
Permanent
Waterford
15 Jun 2020
BBBH761261

QA Manager

Waterford

Competitive Salary & Benefits

My client, a leading Waterford based Pharmaceutical company is currently seeking an experienced QA Manager with experience of Quality Assurance of aseptic medicinal products and in particular biopharmaceuticals to join their team.

As QA Manager you will be responsible for all aspects of assigned QA Team; provide leadership and support to direct reports. Provide QA oversight to ensure that all drug product manufacturing activities are compliant with company policies, procedures and in accordance with cGMPs. And also support the Head of Quality with the quality function oversight

The Role:

  • Maintain the company , Pharmaceutical Quality System to include: Personnel,
  • Premises & Equipment, Production, QC, Outsourced activities, Complaints,
  • Investigations, Self-Inspections
  • Ensure all work carried out is compliant with company standards, cGxP, SOPs,
  • regulations and guidelines, safety and environmental guidelines
  • Continuously promote a positive safety culture. Implement Safety requirements as per
  • site documentation including SOPs, Safety Statement
  • Collaborate cross functionally with all departments and represent Quality on the Sterile
  • Supply Value Stream
  • Investigations management and approval
    • Deviations & Complaints
    • Out-of-Specifications, Out-of-Calibrations, Out-of-Trends
  • Elevate Quality issues to the Head of Quality and Senior Management where required,
  • working collaboratively with the department manager to provide direction and
  • support in critical interventions
  • Manage and host site Inspections (Customer audits / Regulatory inspections etc.)
  • Batch documentation review ensuring compliance to standards and SOP's
  • Batch package preparation for QP release
  • Manage Vendor Qualification
  • API and excipient disposition
  • Primary & Secondary component disposition
  • Provide oversight of any Contract Manufacturing activities related to department
  • Manage metrics, performance and review with the Site Leadership Team
  • Quality management representative on Area Management Team , ensuring
  • effective running of the business
  • Involved in the recruitment, leadership and career development of Quality Assurance
  • members
  • Creation of Quality department goals aligned with site strategy and objectives
  • Performance evaluations for direct reports
  • Quality department budgeting
  • To perform additional tasks as agreed to support effective running of the business.

The Person:

  • Primary degree in a scientific discipline
  • 8+ years' experience in the biopharmaceutical industry, 5 of which should be

within a Quality function

  • Minimum 4 years leadership experience, including team coaching and development
  • Experience of Quality Assurance of aseptic medicinal products and in particular
  • Experience in using lean methodologies and / or operating within Value Streams
  • A candidate who is eligible to act as a Qualified Person as described in EU Directives, would

be an advantage

  • Extensive knowledge of electronic QMS systems - EDMS, ERP, TrackWise etc.
  • Experience preparing and hosting Customer & Regulatory Inspections
  • Lead auditor experience
  • People management skills
  • Project management, MS project
  • Knowledge of electronic document management system and electronic deviation / CAPA systems

This is an excellent opportunity for an experienced QA Manager who is looking to take the next step in their career within an innovative and cutting edge organisation. If you would like to arrange a confidential conversation to discuss this role please apply using the link below.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF LA CRÈME SERVICES.

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