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Qualified Person

Job Title: Qualified Person
Contract Type: Permanent
Location: Cork
REF: 85178
Job Published: about 2 years ago

Job Description

Qualified Person

Our client a leading global pharmaceutical company requires an experience QP for a permanent role.

This position is responsible for carrying out tasks and projects related to management of Quality Assurance activities at JSCI as required by Good Manufacturing Practice (GMP). These activities include Material release, Change control, Event management, supplier qualification, and Annual product review and validation compliance activities. And also provide support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met.

Key Responsibilities:
  • Carries out tasks related to the administration of event management systems including Review & Approval of Event, Deviations, and Customer complaints.
  • Batch Record Review & material release to ensure compliance with GMP
  • Carries out tasks related to the management of batch records design and approval. Ensures that Batch Operating Instructions are compliant with filed descriptions.
  • Carries out tasks relating to the management of site change control systems.
  • Supports & GMP conducts GMP/ICH Q7 training as required.
  • Compiles Annual Product Reviews.
  • Supports all validation activities on site as described in the Site Validation Master Plan.
  • Approves and compiles where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.).
  • Supports system qualification and process validation activities.
  • Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance
  • Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site.
  • Participates in the introduction of new process or modified process steps, as part of a New Product Introduction Team (NPI)
  • Perform GMP audits on-site and vendor facilities as required.
  • Carries out tasks related to the administration of site supplier approval process.
  • Adheres to and supports the company safety policy and safety programmers.
  • Engages in Site Credo initiatives
  • Performs QP certification of Sterile API batches (and related activities)
  • Contribute to innovative and viable products, services and/or solutions, adding value. Challenges the status quo and adapt to change, taking advantage of opportunities to have a positive impact.
  • Identifies and communicates meaningful risks, takes appropriate action and demonstrates an awareness of the highest standards of quality and compliance.
  • Take accountability for their performance and development alongside supporting talent acquisition and the development of others.
  • Leverages diverse perspectives, backgrounds and talent to generate effective ideas or solutions and engage in transparent and constructive conversations, contributing to high-performance teams.

Education, Experience and Skills:
  • Qualified Person (QP) qualification and at least 5 years QA/Validation experience.
  • Is Customer focused
  • Innovative and Excellent communication
  • Attention to detail with
  • Good problem solving skills
  • Results and performance driven
  • Adaptable and flexible
  • Experience of Sterile manufacture.
  • Decision making

For further information on this Qualified Person role in Cork please contact Cliona O?Malley on 091730022 /
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