Senior Quality Specialist

Senior Quality Specialist required for a leading Biopharma facility in Co. Cork, to provide Quality oversight, support and knowledge to activities relating to Quality Systems across the site and in meeting the priorities of: Compliance, Supply, Strategy and Profit Plan. Initially an 11 month contract. Please contact Claire. The Quality Specialist will have proven capability in development of Quality Systems as an active member, across cross functional teams, to deliver process improvement. The Quality Specialist will model the Leadership behaviours and understand the MPS principles to drive a culture of continuous improvement building a High-Performance Organisation. The Quality Specialist will participate and comply with the Quality Management System (QMS) requirements, including ownership as required. The role is a shift, full time onsite role providing quality oversight to Operational areas. This role is integrated in the production area. The shift is 5/2, week 1 is M/T/F/S/S all 11-hour days. Week 2 is W/T 11.30 hr days.

Responsibilities:

1. Provides to the site expertise in Quality Systems and/or Operational Quality, including the following: Quality Notifications, Investigations, Change Management, environment monitoring programs, sterility assurance, and low bioburden manufacturing.
2. Uses knowledge to improve Quality Systems and/or Operational Quality; solve complex problems, provide continuous improvement and execute tasks.
3. Acts as a resource to colleagues with less experience in Quality Systems and/or Operational Quality.
4. Understands and applies regulatory/compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
5. Required to be proficient in Quality approval and oversight for Commissioning and Qualification activities (IQ/OQ/PQ).
6. Interprets customer needs, assesses requirements and identifies solutions to non-standard requests.
7. Makes decisions within guidelines and policies which impact Product Quality, Projects and Quality Systems.
8. Provides compliance contribution to project teams and leads small projects.
9. Coaches and guides colleagues within the site.
10. Responds to non-standard requests from customer needs.
11. Supports Corporate Quality to ensure actions related to Quality Systems at the site are executed.
12. Participation in inspections of Site by Divisional/Regulatory Bodies/third parties together with follow-up actions where applicable.
13. Participate in GMP Walkthroughs.
14. Deviation Management & Change Control approval.
15. Ensures supply of high-quality product through the implementation and oversight of the Quality Management System for the site.
16. Champion the highest Quality and Compliance standards for the site.
17. Ensure highest safety standards.
18. Additional activities as requested by QA Lead.

Requirement:

1. Degree or 3rd level qualification (Science, Quality).
2. Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation.
3. 5 years' experience in the pharmaceutical industry or a similar operating environment which includes experience in a Quality function.
4. Quality Assurance SME knowledge, from both operational and educational experience, is required.
5. Knowledge and experience in interpreting current regulatory requirements and providing independent support to the site.
6. Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance.
7. Demonstrated ability to work and succeed within teams as well as leading small project teams.
8. Demonstrated ability to drive the completion of tasks.
9. Proven track record of providing independent Quality support to the site.
10. Advanced PC skills such as Excel, Word, PowerPoint.

Skills: