LSC have an exciting contract opportunity for a Quality Assurance 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 minimum of 2-5 years’ GMP related experience in biopharmaceutical / pharmaceutical or related industry and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Serve as Quality Assurance support and SME for Drug Product manufacturing maintaining knowledge of industry standards and regulatory requirements to ensure all drug manufacturing, storage and shipping activities are compliant
o Providing oversight of GMP systems completed by CMO’s and External Supply Chain function related to Drug Product, Drug Product and Finished Product.
o Provides oversight to continuous quality system improvements and supports implementing improvements at CMO’s in compliance, Preventive Maintenance, Deviation Management and Change Control Programs as they impact the company
o Works closely to build relationships with contract manufacturers quality personnel
o Works closely with internal cross-functional impacted areas, such as External Plant Operations, CMO Management, CMC/Regulatory Affairs and Technical Services to resolve open issues in a timely manner resulting from record reviews and deviation events
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o Bachelor’s degree required; preference given to candidates with advanced degrees; 2 or more years cGMP experience preferred including QA validation experience; consideration will be given to other relevant experience and education.
o Must have experience/knowledge of drug product/finished product manufacturing processes in a cGMP environment
o Must have knowledge of industry best practice and current regulatory expectations concerning drug product, drug product and finished product manufacturing.
o Minimum of 2-5 years’ GMP related experience in biopharmaceutical / pharmaceutical or related industry
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!
To apply submit your CV via this advert or contact Regina Carroll at LSC on 021-4777329 if you have more questions about this Quality Assurance Specialist opportunity!