LSC have a great contract opportunity for an Associate Quality Specialist (Quality Systems) to join a global Biopharmaceutical company in Cork. The facility specializes in the fermentation, purification, and sterile filling of biotech products, as well as supporting product development and clinical trials.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Required to be proficient in Quality approval and oversight for Commissioning and Qualification activities (IQ/OQ/PQ)
- 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.
- Makes decisions within guidelines and policies which impact Product Quality, Projects, and Quality Systems.
- Provides compliance contribution to project teams and leads small projects.
- Supports Corporate Quality to ensure actions related to Quality Systems at the site are executed.
- Deviation Management & Change Control approval.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Degree or 3rd level qualification (Science, Quality).
- 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.
- Demonstrated ability to work and succeed within teams as well as leading small project teams.
- 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.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Grainne Hodnett @0214777329 if you have any more questions about this opportunity!
