Senior Specialist, Sterility Assurance
Alvotech · Reykjavík
Key responsibilities and minimum requirements according to job level:
- Contribute to the documentation and management of microbial control strategy for DS and DP production processes from Incoming good to final product.
- Provide Sterility assurance and Microbiology expertise to operations to ensure manufacturing meets cGMP standards and regulatory expectations.
- Provides oversight to facility and quality systems state of compliance with internal requirements and appropriate regulations and participates in the development of action plans to correct deficiencies and improve quality processes.
- Provides microbial and aseptic expertise to lead and support EMI, Deviations, CAPAs and complaints related to DS and DP manufacturing.
- Supports site internal inspections, Regulatory and Client audits.
- Author/review/approve GMP documents including but not limited to SOPs, batch records, protocols, reports and specifications.
- Be an SME author of deviations, CAPAs and change controls relating to sterility assurance and microbiology as required in span of expertise.
- Responsible for own continuous professional development to maintain up-to-date knowledge of new regulatory requirements as well as technical developments relevant to own area of expertise. Proactively share knowledge for the benefit of others.
- As a trained trainer, train, coach, and mentor, help to provide guidance and support for less experienced member of staff.
- Accountable for ensuring quality metrics and KPIs are maintained in control for areas of responsibility.
- Responsible for handling and support of Environmental Monitoring and Personnel Monitoring excursion investigations.
Accountable for the following functions and responsibilities:
- Planning & Scheduling of Microbiological sampling, testing, resource allocation and
responsible for associated KPIs.
- Supporting site wide microbiology program and projects
- Support all QMS workflows and Microbiological test record reviews for batch disposition.
- Act as a backup for all activities related to Microbiology laboratory and associated
- documentation.
- Lead / support EMPQ, EM trending and reporting
- Handling EMIs and PMIs
- Support site Gowning regime
- Support site Cleaning regime
- Lead Disinfectant Efficacy Studies and Implementation
- Lead site Contamination Control Strategy
- Lead Viral and Microbial control strategies
- Support Audit readiness sitewide
- Support Smoke Studies Planning and Reporting
- Lead Microbial Risk Assessments
- Support in ensureing Cleanroom behaviour – Aseptic Behaviours
- Support Cleanroom behavior training
- Support APS Planning, Risk Assessment, Protocol writing and Reporting
Competencies required to fulfill the employee responsibilities and work assignments:
- An employee shall follow the job description that pertains to his/her position. In addition, an
employee shall follow the SOPs that pertains to his/her position Keeping training overdues to a minimum.
- An employee shall adhere to and set an example for the Company’s etiquette in all matters of behavior and manners. The employee shall take the initiative when solving a task
assigned to him/her and do whatever is necessary to solve it.
- It is important that an employee has the company values at the heart in his/her work.
- An employee shall be actively involved in tasks that involve other departments in the
company, in addition to other tasks assigned to him/her.