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Employer Pe Global
Job Title QA Specialist - East Cork
Description

PE Global is currently recruiting for a QA SPECIALIST for a Client site in Cork:

Description:

  • This position is responsible for carrying out tasks and projects related to managing compliance activities during qualification and validation related to projects as required by Good Manufacturing Practice (GMP).
  • These activities include review and approval of change controls, nonconformance investigations, and protocols. Primary Tasks and Responsibilities
  • Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following the Standard of Leadership behavior model.
  • Partners with other Departments to ensure that compliance systems are implemented in an efficient manner.
  • Supports the management of GMP compliance systems through the following activities:
  • Assesses compliance systems on ongoing basis to identify opportunities for process improvement.
  • Carries out tasks related to the administration of project and site nonconformance management systems: Reviews and/or approves nonconformance investigations and their associated documentation. Manages entry of nonconformance records into the appropriate electronic system.
  • Tracks investigations from the initiation through closure processes and advises relevant personnel on the status of investigations and associated CAPA and commitments, as appropriate.
  • Coordinates investigation activities to ensure root causes are identified and that corrective actions are appropriate.
  • Approves closure of nonconformance investigations on completion of the investigation and associated corrective actions.
  • Carries out tasks related to the management of project and site change control systems:
  • Reviews and/or approves change control requests, implementation actions, and request closures.
  • Manages entry of change control records into the appropriate electronic system.
  • Tracks records from the initiation through closure processes and advises relevant action to take

Qualifications and Experience:

Essential

  • Bachelors Degree in a scientific/technical discipline required
  • A minimum of 2 years’ experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
  • Demonstrated knowledge and application of industry regulations as they apply to qualification and validation, including those of FDA, IMB, EMEA and other authorities.
  • Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
Desirable

  • Experience in statistical sampling plan development.
  • Experience in a biopharmaceutical or pharmaceutical plant startup.
Other Skills, Experience and Education

  • Influence and facilitate the work of other departments and functions in achieving and maintaining state of GMP compliance.
  • Establish effective partnerships with other individuals, departments and GBSC affiliates so that compliance activities are well understood and coordinated.
  • Actively promote improvement programmes towards continuous compliance during qualification and validation.
  • Actively promote and apply strategic thinking to compliance activities
  • Facilitates the work of other departments and functions in achieving and maintaining state of GMP compliance during qualification and validation activities.
  • Establishes effective partnerships with other individuals and departments so that quality systems and compliance activities are well understood and executed to a high standard.
  • Interface with all site departments, Operations and Maintenance.
  • Contact with Quality Assurance Manager for management of qualification and compliance activity.
  • Directors and managers of other departments for coordination of qualification document reviews and approvals, including associated change controls, non-conformance investigation, and completion of commitments.

Interested candidates should send their CV to Audrey.brennan@peglobal.net or call 0214297900

This job originally appeared on RecruitIreland.com
Location Cork
Date Added 13 days ago
Apply Link
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