Quality , Science, Pharmaceutical & Food

Quality Assurance Specialist

Posted 13 hours ago
Contract
Cork, County Cork, Ireland
41989555

PE Global is currently recruiting for a Quality Assurance Specialist on behalf of our client based in Cork.

This is an initial 11 month contract role

QA/ QIPT Associate Specialist/ Specialist

Purpose of Role:

The Quality Assurance Associate Specialist/ Specialist will provide Quality oversight, support and knowledge to activities relating to Quality Systems across the site and in meeting the Manufacturing Division Priorities of: Compliance, Supply, Strategy and Profit Plan.

Activities Within Role:

This role requires the delivery of a robust Quality Management System to support a flexible, collaborative, multi-skilled teamwork environment.

The team working style is one of collaboration, coaching and facilitation to ensure the success of the site. The Associate Specialist/ Specialist is accountable for the Quality Systems within the site.

Primary activities/responsibilities:

Provides to the site knowledge and experience in Quality Systems and/or Operational Quality, including the following i.e. Quality Notifications/ Investigations/LIR coaching; GCM coaching, environmental monitoring program, sterility assurance/low bio-burden manufacturing, customer complaint investigations etc.
Uses knowledge to improve Quality Systems, solve problems, provide continuous improvement and execute tasks.
Provides compliance contribution to project teams and leads small projects.
May coach and guide colleagues within the site.
Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
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 and/or Operational Quality at the site are executed.
Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.
Ensure supply of high quality product through the implementation and oversight of the Quality Management System for the site.
Ensure the highest Quality, Compliance and Safety standards.
The Associate Specialist/ Specialist will participate and comply with the MMD Quality Management System (QMS) requirements, including ownership.
Responsible for driving a culture of Continuous Improvement by deploying Six Sigma tools within across operational areas.
The Quality Associate Specialist/ Specialist will have proven capability in development of Quality Systems as an active member, across cross functional teams, to deliver process improvement. Model the Leadership behaviours and understand the MPS principles to drive a culture of continuous improvement building a High Performance Organisation.

Requirements:

1 – 5 years’ experience in the pharmaceutical industry or a similar operating environment which includes experience in a Quality function
Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (i.e. Quality, science etc.)
Operational experience of at least 4 QMSs
Degree or 3rd level qualification (Science, Quality)
Quality Assurance SME knowledge, from both operational and educational experience, is required
Demonstrated use of Leadership Behaviours
Knowledge and experience in interpreting current regulatory requirements and providing independent support to the site
Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance
Demonstrated ability to work and succeed within teams as well as leading small project teams
Demonstrated ability to drive the completion of tasks
Proven track record of providing independent Quality support to the site.
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
Demonstrated coaching skills
Demonstrated ability to solve problems
Lean Six Sigma Yellow Belt or suitable alternative

Behaviours

Focus on Customers, Including Patients
Focus the entire organization on delivering value for customers, including patients, by understanding and meeting their needs.
Collaborate
Actively listen and seek to understand differing perspectives; work together to achieve the common goals
Act with Candor and Courage
Speak openly, honestly and with conviction; have the courage to take appropriate risks and make difficult decisions.
Make Rapid, Disciplined Decisions
Make timely decisions at the right level with the right data, and support them once made.
Drive Results
Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results.
Demonstrate Ethics & Integrity
Adhere to the highest standards of trustworthy and ethical behavior in all interactions and hold others to the same standards; comply with all laws, policies and regulations; identify and address ethical issues without hesitation.