- Providing quality and cGMP input and oversight for all start-up project activities through commercial readiness for 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 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.
- 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.
- Supporting the Raw Material and Vendor Qualification Program.
Developing and reporting quality metrics
Deputizing for the Manager of Quality Operations during holidays and occasion of absence as required.
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 to various audience levels
- Academic degree in natural or applied sciences (Pharmacy, Biology, Biotechnology, Engineering
- Minimum 5 years in international pharmaceutical and/or biotech industry with increased level of responsibility
- Sound awareness and understanding of quality and regulatory requirements
- Demonstrated success records in auditing and inspection processes
- Ability to operate efficiently in a complex matrix organization and international environment
- Strong mature leadership and interpersonal influencing skills
- Demonstrated history of Continuous Improvement applying LEAN/6 sigma tools.
We would prefer for you to have:
- A qualification in a Pharmaceutical Quality related discipline
- Efficiency in SAP, EDMS, MES and Trackwise.