Senior QA Specialist
My globally renowned client is currently recruiting for a new Quality Assurance team as part of continued investment in their plant-based technology and capabilities. This position is one of several key positions onsite as part of a global investment program centered on cutting edge manufacturing technology for the biopharma industry and is a fantastic opportunity for the right individuals to take on leadership responsibilities in one of the most exciting technical areas of the industry.
Main Responsibilities:
- Work as part of an experienced QA team involved in day to day operational QA activities in support of manufacturing
- Set long term objectives and work with senior management to deliver KPIs related to quality across site
- With support from the employer undertake training and development in key areas of expertise to gain the ability to act as site subject matter expert
- Play a key role in aspects of Regulatory and customer audits
- Participate actively or lead in deviation investigations, change controls, CAPA plans
- Ensure adherence to site SOP's and policies and act as champion within QA and manufacturing.
- A competent Reviewer and Approver of SOPs, protocols, reports or records.
- Lead a small team and provides supervision to QA Coordinators, interns or Specialists.
Requirements:
- Bachelor's degree in a relevant scientific subject
- At least 5 years' experience of working in QA
- Experience of managing or supervising small teams with QA/Operations is highly desirable
- Knowledge of working in a sterile/aseptic biopharma manufacturing environment is highly desirable.
- Experience in leading quality focused projects in a manufacturing environment such as CAPA, deviation, ROOT Cause analysis projects will be essential for success in this role
- Knowledge of lean/six sigma as part of a GMP environment will be desirable
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).