QA Sterility Manager
Leads a specialised team across site as part of a global investment program in biopharma manufacturing Provides expert support to business partners including production, MSAT, Engineering, QC and QA assuring adequate facilities contamination prevention practices, monitoring tools are provided to production to guarantee the best results.
Responsibilities
- Is a sterility assurance SME who contributes to the site Local and Global sterility assurance and contamination prevention, continuous improvement and harmonization programs.
- Provides expert coaching and mentoring support locally on sterility assurance knowledge, practices and sterility awareness as part of the developing culture for the site.
- Responsible for the generation of key performance indicators, regulatory compliance and efficiency targets.
- Challenges technical and scientific aspects of the facilities design and aseptic principals, with Production, QA, QC, and Engineering etc.
- Maintenance of specific SOPs, documentation, audits, training, cGMPS and method validation for specific area of responsibility.
- Ability to communicate quality operations and compliance perspective effectively to senior management.
- Involvement in global harmonization/ efficiency projects; begin to lead aspects of global projects within specific areas.
- Responsibility to drive the focus on safety to the QA Sterility staff and into functional areas that routinely support biopharma manufacturing.
Requirements:
- Engineering/ Life Science Diploma/Degree or higher from recognized institution
- Minimum of 7 years of QA or QC Sterile processing and Microbial experience in similar capacity
- GMP experience in the biologics industry is required
- Experienced in team management and leadership
Please send your resume in WORD format by clicking the apply button below or contact Jochen Surrey on +65 6701 1516 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1878834 (Jochen Nico Surrey).
