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Senior QA Specialist

I7678D

Senior QA Specialist required for West Dublin based Pharmaceutical client

Category:
Quality
Location:
Leinster
Years of Experience Req.:
5 Years+
Date Posted:
23/07/2019
Days Remaining:
10
Employment Type:
Contract
Education Level Req.:
See Description

Senior QA Specialist

Duties:

  • Work with Manager, Quality Assurance and staff to foster an ethos and culture of cGMP & Quality awareness, where the cGMP’s and Quality are an integral part of the overall business.
  • Ensure that plant and processes are run in compliance to current Good Manufacturing Practices (cGMP), including data integrity. Provide effective real time support for manufacturing operations including QC in batch record review, deviation and incident management, CAPA development, change management, complaint investigations, cleaning activities and purified & process water system support.
  • Represent Quality Assurance in support of Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
  • Support audit program including Internal and external auditing and regulatory / customer inspections.
  • Compilation and review of QA SOPs
  • Support warehouse operations including finished product labeling / shipping checks, and temperature mapping activities to ensure compliance with Good Distribution Practice,
  • Support  program for outsourced service providers
  • Review & approval of plant, warehouse and QC procedures.
  • Providing quality input and support the resolution of technically complex issues within manufacturing operations in compliance with cGMP requirements, ensuring decisions made maintain product quality. 
  • Review and approval of relevant protocols, as appropriate.
  • Involvement in site-wide projects and support operational excellence initiatives.  
  • Support Key User activities for QA systems (including LMS and TrackWise)
  • Ensure compliance with relevant regulations and standards associated with ISO 14001, EMAS, Health & Safety Legislation, Environmental Legislation, and also all site standards, policies, and procedures.

Requirements:

  • Minimum requirement: Third level qualification in Science or Engineering discipline preferably with 5 to 7 years experience of working in a GMP environment.
  • Knowledge of regulatory requirements related to pharmaceutical manufacture.
  • Able to work effectively using own initiative and have good organiz767517.111354ational skills
  • Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels
  • Efficient in document management systems and TrackWise desirable, or other quality management systems.

 

DPS Engineering is an Equal Opportunities Employer.

Recruitment Agencies: Please do not reply to this job advert.

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