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Quality Specialist (Projects)

I7131

Quality Specialist required for large Pharmaceutical site upgrade in East Cork

Category:
Quality
Location:
Munster
Years of Experience Req.:
5 years
Date Posted:
11/03/2019
Days Remaining:
27
Employment Type:
Contract
Education Level Req.:
Degree qualified

Quality Specialist

DPS Engineering currently has a requirement for a Quality Specialist for an API Facility/Process upgrade in East Cork. The successful candidate will be responsible for managing compliance activities and Quality activities such as C&Q and Validation, Risk assessments, Data Integrity, change control, Deviation and other related quality system elements. 

 

Responsibilities;

  • Ensure that quality standards are implemented on the project
  • Ensure compliance with quality and industry regulatory requirement
  • Provide professional and timely inputs/directions and ensure the right level of quality in projects.
  • Prepare data/reports to communicate outcomes of quality activities.
  • Attend meetings (e.g. board/project/portfolio/department meetings).
  • Identify training needs and organiz701824.804914e training interventions to meet quality standards.
  • Ensure update of Quality documentation: write Procedures and directions for recording and reporting quality data in projects, for documentation owned by Quality departments.
  • Ensure the link between Project Manager and Regulatory Responsible on site.
  • Reviewer/Approver of Change Controls.
  • Reviewer/Approver of Qualification/Validation Documents (e.g. validations (master) plans/reports, (User) Requirement Specifications, DQ, IQ, OQ, PQ, PPQ/PV, RCL, RTM, risk assessments, SOPs).
  • QA oversight of qualification and validation activities on the project
  • Participating in continuing professional development in order to maintain awareness in current and new regulations and ensuring new regulations are implemented.

 

Qualifications and Experience:

  • Minimum qualification of a Bachelor Degree in a scientific/technical discipline required
  • 5 years’ experience working with quality and cGMP in the pharma industry.
  • Experience in C&Q and life cycle qualification/validation support.
  • Skilled in the execution of Risk Assessment and in the use of a variety of problem solving techniques

 

DPS is an Equal Opportunities Employer.

 

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

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