Associate Quality Specialist

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.

Primary activities/responsibilities:

• Provides to the site expertise in Quality Systems and/or Operational Quality, including the following i.e. Quality Notifications/Investigations/ Change Management; environment monitoring programs; sterility assurance/low bioburden manufacturing; etc.
• Uses knowledge to improve Quality Systems and/or Operational Quality; solve complex problems, provide continuous improvement and execute tasks.
• Acts as a resource to colleagues with less experience in Quality Systems and/or Operational Quality
• Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes
• 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.
• Makes decisions within guidelines and policies which impact Product Quality, Projects and Quality Systems.
• Uses knowledge to improve Quality Systems, solve problems, provide continuous improvement, and execute tasks.
• Provides compliance contribution to project teams and leads small projects.
• Coaches and guides colleagues within the site.
• Responds to non-standard requests from customer needs.
• 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.
• Participate in GMP Walkthroughs.
• Deviation Management & Change Control approval.
• 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.
• Additional activities as requested by QA Lead

Required:

• Degree or 3rd level qualification (Science, Quality).
• Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation.
• 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.
• 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.
• Energetic with proactive & positive attitude.
• Demonstrated coaching skills.
• Demonstrated ability to solve problems.