LSC have a great contract opportunity for a QA Specialist to join a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products.
If you have 4 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
The QA Senior Specialist for Quality Operations will be responsible, with management support, for providing oversight of quality activities associated with Quality Control at the manufacturing facility.
- Responsible for the quality oversight for Quality Control (QC) related activities for testing activities, method transfer, method validation, retain and stability program. This includes raw materials, clinical and commercial products for Drug Substance, Drug Product, and Finished Product
- Responsible for quality oversight of QC certificate of analysis
- Provide QA oversight and guidance of change controls, Laboratory Investigation Reports, deviations, Quality Control SOP's, method transfer documentation, validation and qualification documentation and test related documentation
- Provide Quality input, oversight and guidance to Alexion deviations and investigations to ensure robust root cause analysis/CAPA definition and timely closure as per company SOPs and QMS.
- Perform batch documentation review, management of changes, complaints, deviations, validations and product annual reviews related to operations
- Provide oversight to continuous quality system improvements and support implementation of improvements in compliance, Preventive Maintenance, Deviation Management and the Change Control Programs
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Primary Degree in Science (Chemistry, Microbiology or Pharmacy preferred)
- Minimum 5 years in international pharmaceutical and/or biotech industry with increased level of responsibility
- Experience in Quality department, QC / QA is preferable
- Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements
- Demonstrated success records in auditing and improvement processes
- Ability to operate efficiently in a complex matrix organization and international environment
- Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels
- Efficient in SAP, EQV, ECMS, LIMS
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 Kathy Gillen at LSC on 021 4777329 if you have any more questions about this role!
