Quality Officer

Republic of Ireland  ‐ Onsite
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Keywords

Description

Purpose of the Job:

To ensure the business is in compliance with regulatory requirements by timely review and release of batch documentation and conducting process, packing, cleaning and temperature mapping validation of all areas against the regulatory standards.

Specific Key Result Areas:
  • Routine Product Release: To conduct documentation review of entire batch package in line with regulatory requirements, including where applicable, OOS /Stability reports.
  • New Products / Validation: To generate, review and conduct process, packing, cleaning and temperature mapping validation reports in line with current regulations and industry best practice, within required timelines. Quality support for introduction of new products, equipment and facilities.
  • Quality Systems Development: To develop and improve quality systems by identifying areas for improvement (NVAA's and key variances) and take corrective action as required to ensure continuous improvement in accordance with Company Continuous Improvement Process.
  • To ensure that all work carried out is in Compliance with the required standards conforming to company, cGMP, cGLP's, SOP's, regulatory regulations and guidelines, H&S and environmental guidelines.
  • Review and approval of change proposals and related documentation for compliance with regulatory approvals and GMP requirements. Review, trending and assistance in managing of deviation reduction in conjunction with relevant departments. Generation and approval of Technical Agreements.


Support
  • To deliver Customer Service (both internal and external) through agreed timelines in accordance with quality standards and cost control.
  • Participate in CI activities / projects / root cause analysis and solution implementation to enhance the product value streams.
  • To conduct simulated IMB/FDA systems inspections to ensure the company is at all times ready for audit. Conduct audits of Suppliers where necessary and provide assistance to the Vendor Certification Programme.


The successful candidate should possess the following:
  • Degree/Diploma or equivalent in Pharmaceutical/Life Sciences with two years experience in a Validation or QA environment.
  • In depth knowledge and understanding of interpretation of cGMPs and regulatory requirements, experience of regulatory inspections and customer audits.
  • Understanding of Production and Laboratory systems to effect decisions consistent with business needs.
  • An understanding of internal/external customer requirements and an ability to respond promptly to needs.
  • Ability to participate in day to day activities and projects by providing Quality support across the entire Value Stream.
  • Ability to work on own initiative to meet and exceed business objectives.
  • Experience with Trackwise, SAP and strong report writing skills.


This is an exciting opportunity with competitive hourly rates. If you would like to apply please contact Sarah Irvine on or submit your CV. We also offer €200 worth of vouchers for any successful referrals.
Start date
02/2015
From
Real Staffing
Published at
16.02.2015
Project ID:
851684
Contract type
Freelance
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