As an Associate Manager, QA you will supervise the day-to-day Quality Assurance activities in accordance with approved SOPs / Policies.
What you will get
- An agile career and dynamic working culture in a global life sciences leader.
- An inclusive and ethical workplace that values diversity and integrity.
- Competitive compensation programs that recognize high performance.
- Professional growth opportunities through cross-functional projects and global exposure.
- Comprehensive medical insurance, with the option to enroll family members at partially subsidized premiums.
- Company transport provided from designated MRT locations to and from the Tuas site.
- Access to Lonza's full suite of employee benefits:
What you will do:
- Supervise the day-to-day operation of approved Quality Assurance Sops I Policies for cell and gene therapy contract manufacturing facility
- Provides support in backroom / front room, participate and front in regulatory
inspections and customer audits as required - Mastery and knowledge of processes is recognized by colleagues as a source of expertise
- Strong understanding of advanced CGMP and develop others in understanding advance CGMP
- Is recognized by colleagues as a source of expertise in CGMP and compliance
- Identify problems, troubles hoot and complete or coordinate corrective action
- Review more complex decisions with supervisor and other departments
- Strong planning and prioritization of activities for self and team without supervision
- Communicate quality operations and compliance perspective effectively to management
- Involvement in global harmonization/ efficiency projects begin to lead aspects of global projects within specific areas
- Understand and articulate company business strategy. Maintain a broad view of the
- business, recognize changes and trends in the appropriate area in which the individual operates
- Own and lead special projects, often complex in nature
- Make suggestions for cost savings
- Any other tasks as and when assigned by Manager/Director.
What we are looking for
- Extensive experience in in Operations/ Validation / Quality Unit in the pharmaceutical / biotech industry
- Degree from recognized institution
- Relevant QA Operations background from the Biopharma environment
- Hands-on experience coordinating & interacting with internal departments on manufacturing activities.
- Good knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility.
- Meticulous and Systematic.
- Team player, with strong focus on safety, quality and timelines
