Position Summary
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 authorizations'. 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. This position is a shift position, operating in extended days (7am-7pm, 4 days on, 4 days off).
Principal Responsibilities
- Provide quality and cGMP input and oversight for all commercial manufacturing in the BDS facility.
- Review and approval of executed batch records in accordance with Alexion’s internal procedures and GMP principles.
- Review and approval of Master Batch Records in accordance with Alexion’s internal procedures and GMP principles.
- Review and approval of Master electronic Batch Record recipes in accordance with Alexion’s internal procedures and GMP principles.
- Review and approval of technical support documentation. (Examples include cleaning, process, method validation).
- Review and approval of functional area documentation (SOPs, Work Instructions, technical reports and protocols).
- Participate in quality risk assessments and provide quality oversight to ensure quality risk assessments are effectively maintained/ controlled.
- Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions.
- Provide oversight of quality management system activities including Preventive Maintenance, Deviation Management and the Change Control Programs.
- Provide quality oversight of calibration and preventative maintenance criticality assessments as required.
- Author, review and approve Quality Related Procedures as required.
- Support the Supplier Management Program.
- Complete review and releasing raw materials and components as required to support manufacturing operations.
- Develop and report quality metrics.
Qualifications
- English fluency written and spoken (the Company language).
- Strong verbal and written communication skills with well-structured communication and presentation ability.
- Ability to operate efficiently in a complex matrix organization and international environment.
- Minimum 3 years in pharmaceutical and/or biotech industry.
- Strong mature leadership and interpersonal influencing skills.
- Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements.
Education
- Academic degree in natural or applied sciences (Pharmacy, Biology, Biotechnology or Engineering).
Date Posted
19-Dec-2024
Closing Date
05-Jan-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.