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QA Manufacturing Operations Specialist (contract) - Dublin

QA Manufacturing Operations Specialist (contract) - Dublin

Job Title: QA Manufacturing Operations Specialist (contract) - Dublin
Contract Type: Contract
Location: Dublin, Republic of Ireland
Industry:
Salary: Negotiable
Start Date: ASAP
Reference: QASpecialist_1503043077
Contact Name: Nathan Wilson
Contact Email: n.wilson@sciproglobal.com
Job Published: August 18, 2017 08:57

Job Description

Responsibilities

  • QA support of manufacturing operations through start-up and onto routine commercial operations
  • Implementation of batch record review process and on the-floor support of manufacturing activities
  • QA Operations review of events and investigations
  • Authoring, review and approval of QA-related procedures
  • Review and approval of functional area documentation
  • Support the Disposition process for Drug Substance and ensure material availability for Manufacturing through release of raw materials and consumables
  • Participation in GMP reviews for new facility construction and new equipment support systems
  • QA support for implementation of Manufacturing Execution System (MES) and development of batch records
  • QA support for implementation of the Enterprise Resource Planning System (SAP) including data verification and integration testing for the Quality function
  • Change control assessment and CAPA evaluation/CAPA close-out
  • Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements
  • Support OPEX programs and champion continuous quality improvement initiatives

Qualifications

  • Hold a BSc in Science or related discipline, with minimum 3 years' QA or related experience in a Pharmaceutical environment.
  • A clear understanding of cGMP requirements for manufacturing and/or systems and compliance.
  • The QA Specialist will be required to work on his/her own initiative in addition to working as part of a team, and must be open to shift work.
  • The candidate must be able to work across a team matrix in order to meet accelerated timelines.
  • Excellent communication & presentation skills are essential.

The successful candidate must demonstrate excellent time management & organisational skills along with a proven ability to multi-task.

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