LSC have a great contract opportunity for a Senior 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.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
The successful candidate will be responsible for providing technical and/or engineering support for Finished Product (FP) manufacturing, providing packaging engineering support through all phases of the commercial finished product lifecycle, including technology transfer, validation, and routine FP commercial manufacturing. This involves providing technical support to manufacturing operations at contract manufacturing organisations (CMOs) used as Client pack sites. The position requires effective cross-functional collaboration with external contractors and internal partners including internal FP subject matter experts, New Product Introduction (NPI), Internal/External Manufacturing Operations, Quality, Marketing and Regulatory partners.
Responsibilities
- Providing technical support to biologics, small molecule and combination medical device product packaging development at CMOs.
- Support troubleshooting efforts and high-level deviation investigations in conjunction with CMOs and internal partners.
- Ownership and management of Change Controls and Risk Assessments executed in support of Packaging Development activities.
- Technical writing of Packaging Tech Transfer Protocols, Packaging Technical Studies and User Requirements Specifications as applied to Packaging Tech Transfers and Launches.
- Collection, organisation, trending, and analysis of Packaging Development data.
- Provide input and other technical documents for regulatory agency submission in support of FP manufacturing processes at internal/external FP manufacturing sites.
Requirements
- Bachelors degree in engineering preferred (or similar technical qualification / equivalent experience in pharma or medical device packaging development).
- Understanding of cGMP requirements for biopharmaceutical manufacturing.
- Strong communication ability to present and influence.
- Organized analytical thinker with strong attention to detail.
- Excellent oral and written communication skills, including technical writing.
- MS Excel, MS Word, MS Powerpoint proficiency
- Experience of using systems within a GMP environment such as Change Control and Document Management systems.
Preferable
- Exposure to Project Management principles and tools.
- Experience of MS Project or other project management software.
- Exposure/experience of Risk Assessment in a cGMP environment
