LSC have a great contract opportunity for a QA Specilaist 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:
- Serve as Quality Assurance support and SME for Drug Substance, Drug Product and Finished product manufacturing maintaining knowledge of industry standards and regulatory requirements to ensure all drug manufacturing, storage and shipping activities are compliant
- Providing oversight of GMP systems completed by CMO's and External Supply Chain function related to Drug Substance, Drug Product and Finished Product.
- 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
- Works closely to build relationships with contract manufacturers quality personnel
- 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?
- Bachelor's degree required; preference given to candidates with advanced degrees; 2 or more years cGMP experience preferred; consideration will be given to other relevant experience and education.
- Must have experience/knowledge of drug substance, drug product and finished product manufacturing processes in a cGMP environment
- Must have detailed knowledge of industry best practice and current regulatory expectations concerning drug substance, drug product and finished product manufacturing
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 Pawel Jurkiewicz at LSC on 021-4777329 if you have anymore questions about this QA Specialist - External Quality opportunity!