LSC have a great contract opportunity for a Quality Specialist to join a leading biotech company based in Dublin.
If you have 5 years of relevant post-degree work experience in GMP Manufacturing, Pharmaceutical/Biological Quality, Operations/Technical and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Participates as the quality member on cross functional projects
- Responsible for review/approval of new and updated Master Batch Records / Electronic Batch Records
- QA support, review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.
- Quality SME for Performance qualification (PQ) activities across the site including but not limited to: Equipment, Facility and Utility PQ studies, Cleaning Validation, SIP, process validation,
- Support sustaining activities such as Change Management, Deviations, CAPAs, Equipment Requalification and Periodic review, Site Maintenance & Calibration Program
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Bachelor degree, in a scientific or engineering field
- Minimum 5 years of relevant post-degree work experience in GMP Manufacturing or Laboratory environment, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting
- Evidence of leadership skills coupled with good oral and written communication skills
- Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area
- Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment
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!
Call in Grainne Hodnett at LSC on 021 4777 329 to discuss this new role in detail or apply directly via this advert
