KEY RESPONSIBILITIES:
- 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.
REQUIREMENTS:
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.
