R.T. Lane Recruitment are currently recruiting for a QA Specialist – Quality Systems to work with a Pharmaceutical Company in Cork.
This is an 11-month contract with strong potential for extension.
Please note that candidates must hold the correct working visa for Ireland as my client cannot offer visa assistance and must be already residing in Ireland.
Roles and Responsibilities:
* Contribute to the site expertise in Quality Systems and/or Operational Quality.
* Support more junior members of the team.
* Keep up to date on current and new industry requirements and regulations.
* Required to be proficient in Quality approval and oversight for Commissioning and Qualification activities (IQ/OQ/PQ).
* Interprets customer needs, assesses requirements and identifies solutions to non-standard requests.
* Uses knowledge to improve Quality Systems, solve problems, provide continuous improvement, and execute tasks.
* Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
* Supports Corporate Quality to ensure actions related to Quality Systems at the site are executed.
* Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.
* Ensures supply of high-quality product through the implementation and oversight of the Quality Management System for the site.
* Champion the highest Quality and Compliance standards for the site.
* Ensure highest safety standards.
Required:
* Degree or 3rd level qualification (Science, Quality).
* 5 years’ experience in the pharmaceutical industry or a similar operating environment which includes experience in a Quality function.
* Quality Assurance SME knowledge, from both operational and educational experience, is required.
* Demonstrated ability to work and succeed within teams as well as leading small project teams.
* Demonstrated ability to drive the completion of tasks.
* Advanced PC skills such as Excel, Word, PowerPoint.
* Stakeholder management of multiple decision makers, auditors, cross functional teams by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.
* Proven decision-making capability with full accountability and responsibility.
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