LSC have a great contract opportunity for an Associate Quality Specialist 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:
- 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.
- Required to be proficient in Quality approval and oversight for Commissioning and Qualification activities (IQ/OQ/PQ)
- Provides compliance contribution to project teams and leads small projects.
- Coaches and guides colleagues within the site.
- Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.
- Deviation Management & Change Control approval.
- Champion the highest Quality and Compliance standards for the site.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- 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.
- 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!
