LSC have a great contract opportunity for a Senior Specialist to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life.
If you have 3+ years industrial experience and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Preparation, review and approval of Material Qualification Documentation.
- QA disposition of raw materials, level 1 & level 2 consumables.
- Authoring, review and approval of QA-related procedures.
- QA review, assessment and approval activities for Biologics Manufacture, as applicable, for:
- Change controls
- Deviations/Investigations
- Supplier Investigations
- CAPAs
- Supplier Change Notifications (SCN)
- TSE (Transmissible Spongiform Encephalopathy) Certificate
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- BSc in Science or related discipline with QA or related experience in a Biologics or Pharmaceutical environment
- A clear understanding of cGMP requirements for manufacturing and/or systems and compliance
- Knowledge of material qualification & SAP would be a distinct advantage.
- Required to work on his/her own initiative in addition to working as part of a team. Must be able to work across a team matrix to meet accelerated timelines.
- Excellent communication and presentation skills are essential.
- Excellent time management and organizational skills along with a proven ability to multi-task.
Applicants interested in our contracting opportunities within the pharmaceutical sector in Ireland are required to have a Stamp 1G or a Stamp 4 visa. Please understand that we are unable to provide visa sponsorship. Thank you for your understanding.
Apply via this advert or contact Gráinne Hodnett on 021 4777 329 if you have any more questions about this opportunity!
