The role is a shift, full-time onsite role providing quality oversight to Operational areas. This role is integrated into 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-hour days.
Primary activities/responsibilities:
1. Provides expertise in Quality Systems and/or Operational Quality, including Quality Notifications, Investigations, Change Management, environment monitoring programs, and sterility assurance/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, 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 that impact Product Quality, Projects, and Quality Systems.
8. Provides compliance contributions 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. Makes decisions within guidelines and policies impacting own priorities and allocation of time to meet deadlines.
12. Supports Corporate Quality to ensure actions related to Quality Systems at the site are executed.
13. Participates in inspections of the site by Divisional/Regulatory Bodies/third parties together with follow-up actions where applicable.
14. Participates in GMP Walkthroughs.
15. Deviation Management & Change Control approval.
16. Ensures the supply of high-quality products through the implementation and oversight of the Quality Management System for the site.
17. Champions the highest Quality and Compliance standards for the site.
18. Ensures the highest safety standards.
19. Additional activities as requested by QA Lead.
Required:
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, including 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, and PowerPoint.
11. Stakeholder management of multiple decision-makers, auditors, and cross-functional teams by demonstrating the ability to maintain and strengthen trust relationships with people at all levels.
12. Proven decision-making capability with full accountability and responsibility.
13. Energetic with a proactive & positive attitude.
14. Demonstrated coaching skills.
15. Demonstrated ability to solve problems.
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