Associate Manager, QA (CGT) Operations

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