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Quality Director

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Tipperary
  • Sector: Science
  • Date posted: 12/09/2017
  • Job reference: J373901A

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Vacancy: Quality Director

Reporting to: Global VP of Quality (sitting in the US)

As Quality Director, you will be a key member of the Site Leadership Team, guiding in maintaining a robust Quality Management System, allowing us to build the highest quality pharmaceutical products in a progressive and fast paced environment.

Job Responsibilities: Establish and operate the site Quality Management System to meet required Regulations, Guidance documents, as follows:

  • Determine and establish department structure and reporting relationships within the function in collaboration with senior management.
  • Ensure that appropriate SOP's for various GMP functions as necessary are prepared, reviewed, training imparted and approved.
  • Generate and monitor appropriate trends/KPIs for Quality System processes and implement a Continuous Improvement programme for the Quality System
  • Working with Global Quality Management, develop, review, and endorse Quality Standards for the assurance of Good Manufacturing Practice consistent with regulatory requirements and Company objectives.
  • Act as Primary Qualified Person (QP), (we have QP resources on site).
  • Prior to QP release, ensure all commercial batches comply with the requirements of the Marketing Authorisation and have been manufactured according to the principles of cGMP as per 21 CFR 210/211 and Directive 2003/94/EC
  • Prior to QP release, ensure all investigational medicinal product batches comply with the requirements of the Clinical Trial Authorisation as applicable, the Product Specification file and have been manufactured according to the principles of cGMP as per 21 CFR 210/211 and Directive 2003/94/EC
  • Provide QP oversight of manufacturing, packaging, testing and batch review
  • Ensure that independent QA, QP and QC cGMP subject matter expertise is provided with particular focus on process development, manufacturing, packaging, testing, release and supply operations.
  • Ensure that outsource labs, service providers and RM/PM vendors are evaluated and approved.
  • Plan, organize and direct the day to day activities, performance, training and development of personnel within the Quality Department
  • Oversee compliant and robust method transfers to the site
  • Oversee day to day Laboratory Operations
  • Oversee Site Validation Activities, ensuring that processes are validated, analytical methods are validated, facility and equipment are qualified.
  • Oversee site GMP Training Programmes and provide continuous re-enforcement and education/training of cGMP and quality standards to all employees.
  • Support New Product introductions and technology transfer programmes
  • Direct the Company in preparing for audits by Competent Authorities/customers, act as site Lead Site Representative during these audits and ensure satisfactory close-out and responses to issues raised.
  • Demonstrate effective decision making/problem resolution skills and participate in cross departmental problem solving/investigation teams to ensure that all quality issues are handled as per respective SOPs, investigated to identify the root cause/most probable root cause(s) and appropriate CAPA is initiated to avoid recurrence of the quality issue.
  • Actively participate as a member of the Site Leadership Team and partner with the Site Director
  • Incorporate Corporate quality initiatives
  • Oversee quality investigations and internal audits to assess conformance to specifications
  • Create and manage capital expenditure/revenue budget for the Quality unit.
  • Ensure that all quality complaints are acknowledged, investigated and responded to customer within stipulated timeline to complainant. Appropriate CAPA to be initiated to avoid recurrence of the quality complaint.
  • Ensure that product recall is performed if any quality issue investigation reveals that there is direct impact on product identity, strength, quality, and/or purity of drug product during stability studies sample analysis, control sample analysis, complaint investigation.
  • Ensure that stability studies are performed for the products as per regulatory requirements and stability data is reviewed.
  • Ensure that Annual product quality reviews are performed for each drug product and appropriate actions are taken based on the review recommendations (if any).

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