- Provide oversight and quality standards of sterility assurance of the Alvotech facilities (existing and future)
- Provide oversight and sterility assurance expertise to operations to ensure aseptic processing meets international aseptic processing standards
- Oversee the documentation and management of the microbial control strategy for DS and DP production processes from incoming goods to final product
- Contribute to the smooth technical transfer of new processes/product into QC Microbiology
- Ensure usage of qualified utilities/environment for operation to achieve the regulatory requirements for drug substance/product manufacture
- Ensuring issues within the laboratory are resolved with minimum disruption
- Responsible for driving and leading innovation, providing expertise and strategic leadership across the team
- Lead or delegate leadership of improvement projects within the sterility assurance and QC microbiology
- Provide feedback to CLT/ peers / relevant departments on program status, highlighting and mitigating any constraints
- Develop all necessary tools and processes and select the right resources to establish an efficient and transparent working environment within Micro and SA
- Support external contacts including Regulatory Authorities, professional, scientific and regulatory groups, trade associations and consultants to ensure regulatory compliance in support of the Alvotech portfolio
- Provide microbial and sterility expertise for GMP documents including but not limited to SOPs, batch records, APS protocols, validations, and specifications
- Align with all departments to ensure cross functional involvement & feedback is present across projects, ensuring risks are evaluated and minimized by using continuous problem-solving techniques
- Be accountable for ensuring the QC Microbiology laboratory areas and equipment are maintained in a state of inspection readiness by proactive interaction with other departments (e.g., Engineering, Facilities & EHS)
- Anticipate internal and external drivers of changes to strategy, and respond by making rapid, welljudged adjustments to the program plan
- Drive, encourage, coach & manage the support of employees to achieve business goals. Actively develop talent within the teams
- Responsible for keeping the team engaged, motivated, enabled and empowered to achieve their goals and objectives
- Create reporting dashboard of relevant KPIs for QC leadership
- Provide microbiology and sterility assurance expertise during the investigations of deviations or
- OOS
- Be an SME author of CAPAs and change controls relating to sterility assurance and QC microbiology processes as required in span of expertise
- Provides microbial and aseptic expertise to support EMI and complaints related to aseptic and sterile processing
- Support any other quality related duties as required to support department and company
- Accountable for the following functions:
- o Sterility Assurance
- o Microbiology Operations
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