QA Specialist (FTC)
This is what you will do:
The QA Specialist for the Bulk Drug Substance (BDS) facility at ADMF will be responsible for providing oversight of quality activities associated with the manufacture and disposition of bulk drug substances at ADMF.
The QA Specialist is responsible for ensuring that manufacturing, testing, labelling, and storage of Bulk Drug Substances comply with all applicable GMP regulations and the product authorisations. This responsibility includes the oversight of the College Park QMS to ensure that quality and compliance requirements are followed in line with business needs.
The QA Specialist executes the site QA activities at Alexion in order to protect the safety, quality and efficacy of our products, thereby ensuring the availability of correct, safe product for our Patients, and assuring the security of the company’s business and global markets.
This key role must ensure effective interaction with other departments and locations regarding GMP Document review and finished product releases. In particular, this will involve partnering with major stakeholders such as Operations, QC, QPs, Facilities, Engineering and Supply Chain to optimize patient supply.
You will be responsible for:
Providing quality and cGMP input and oversight for all commercial manufacturing in the BDS facility.
Reviewing and approving technical support documentation. (Examples include cleaning, process, method validation).
Reviewing and approving functional area documentation (SOPs, Work Instructions, technical reports and protocols).
Participating in quality risk assessments and provide quality oversight to ensure quality risk assessments are effectively maintained/ controlled.
Providing support for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions.
Reviewing and approving Master Batch Records in accordance with Alexion’s internal procedures and GMP principles.
Reviewing and approving Master electronic Batch Record recipes in accordance with Alexion’s internal procedures and GMP principles.
Providing oversight of quality management system activities including Preventive Maintenance, Deviation Management and the Change Control Programs.
Providing quality oversight of calibration and preventative maintenance criticality assessments as required.
Authoring reviewing and approving Quality Related Procedures as required.
Supporting the Vendor Management Program.
Completing review and releasing raw materials and components as required to support manufacturing operations.
You will need to have:
English fluency written and spoken (the Company language).
Strong verbal and written communication skills with well-structured communication and presentation ability.
Academic degree in natural or applied sciences (Pharmacy, Biology, Biotechnology or Engineering).
Minimum 2 years in pharmaceutical and/or biotech industry.
Sound awareness and understanding of quality and regulatory requirements.
We would prefer for you to have:
A qualification in a Pharmaceutical Quality related discipline.
Proficiency in SAP, EDMS and MES.
Experience in a Lean/6-sigma operated manufacturing environment.