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QA Manager - Sterile Fill Finish

Quality & Laboratory
Waterford
Therese Keohane
Permanent
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Job Reference: JO-2006-65236_1592217539

Summary:

The QA Manager Sterile Fill Finish is responsible for all aspects of assigned QA Team; provides leadership and support to direct reports. Provides QA oversight to ensure that all drug product manufacturing activities are compliant with company policies, procedures and in accordance with cGMPs.



Responsibilities



  • Support the Head of Quality with the quality function oversight

  • Maintain the Pharma, 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 Sterile Fill Finish Manager to provide direction and support in critical interventions

  • Manage Self Inspection Program

  • 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 Sterile Fill Finish

  • 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.



Requirements



  • Primary degree in a scientific discipline

  • Minimum 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 biopharmaceuticals.

  • Experience in using lean methodologies and / or operating within Value Streams

  • Candidate 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



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Talent Consultant:
Therese Keohane
Therese Keohane
Business Unit Lead
Quality & Laboratory
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