LSC have a great contract opportunity for QA Operations Specialist to join a leading biotech company based in Dublin.
If you have 4 years of experience and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Responsible for review/approval of new and updated Master Batch Records / Electronic Batch Records
- Review and approve production documentation such as executed electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures
- Provides presence on the shop floor to support compliance and data integrity
- QA support, review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.
- Will serve as the 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
- Participates as the quality member on cross functional projects
- 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 (preferred)
- Minimum 5 years of relevant post-degree work experience in GMP Manufacturing, Quality Assurance or Laboratory environment, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations.
- Evidence of leadership skills coupled with good oral and written communication skills
- Quality systems, pharmaceutical manufacturing or laboratory processes, authoring and approving GMP documents
- Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment
For our contracting positions in Ireland's pharmaceutical industry, applicants must possess a Stamp 1G or a Stamp 4 visa. We apologize for any inconvenience, as visa sponsorship is not available currently.
Apply via this advert or contact Grainne Hodnett on 021 4777 329 if you have any more questions about this opportunity!
