Description
Role – Quality Specialists – QMS x3Type – 6 month contract
Location – Co. Cork Ireland
Key Responsibilities:
- The Principal Quality Specialist will provide Quality oversight, support and expertise to GMP related activities across the site and in meeting the Manufacturing Division Priorities of: Compliance, Supply, Strategy and Profit Plan.
- The team working style is one of collaboration, coaching and facilitation to ensure the success of the site.
- The Principal Quality Specialist role will reside in Sterile Operations but will provide support to Operational Quality across site.
- This role requires the delivery of a robust Quality Management System to support a flexible, collaborative, multi-skilled teamwork environment.
- The Principal Quality Specialist will have proven capability in development of Quality Systems across cross functional teams to deliver process improvement.
- The Principal Quality Specialist will understand Lean principles to drive a culture of continuous improvement building a High Performance Organisation.
- The Principal Quality Specialist will participate and comply with the Quality Management System (QMS) requirements, including ownership.
- Provides to the site and network, expertise in Operational Quality (includes expertise in a number of the following topics: Deviation/NOE/LIR coaching, Change Control coaching, Environmental Monitoring programme, Sterility Assurance, Customer Complaint investigations, etc).
- Makes decisions within guidelines and policies which impact Product Quality.
- Liaises with Corporate Quality to ensure alignment on actions related to Operational Quality at the site.
- Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.
- Uses knowledge to improve Operational Quality, solve complex problems, provide continuous improvement and execute tasks.
- Coordinates the work of others within the team and in the site
- Acts as a resource to colleagues with less experience in Operational Quality.
- Leads project teams.
- Coaches and guides colleagues within the site and also in the network.
- Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
- Interprets customer needs, assesses requirements and identifies solutions to non-standard requests.
- Ensure supply of high quality product through implementation and oversight of the Quality Management System for the site.
- Champion the highest Quality and Compliance standards for the site.
Key Requirements:
- Degree (in Science)
- Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Quality, Science etc).
- Strong experience in the Pharmaceutical industry or a similar operating environment which includes a time spent in a Quality function
- Quality Assurance SME knowledge from both operation or educational experience, is required
- Demonstrated expertise in Quality Management Systems.
- Knowledge and experience in interpreting current regulatory requirements and providing independent support to the site.
- Proven track record of providing independent Quality expertise to the site.
- Demonstrated successes in a team environment, such as project teams, Lean Six Sigma team, etc.
- Advanced PC skills such as Excel, Word, PowerPoint.
- Certified Auditor is desirable.