This role will be responsible for leading, coordinating, facilitating, and undertaking activities pertaining to lab operations and compliance, with minimal supervision, acting as a role model for other lab colleagues. The role undertakes implementing continuous improvement projects and supporting a lean culture and Right First Time (RFT). The role also represents the QC unit by liaising with internal and external customers.
Key Responsibilities:
- Experience in a wide variety of analytical techniques including but not limited to cell based- Bioassays, Immunoassays, Cell Culture (use of cells to execute bioassays) and Aseptic Technique. Experience with liquid-handling robots is also preferable.
- Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
- Participate in the peer review of analytical data.
- Responsible for providing technical guidance and applying expertise and critical thinking to help to resolve technical issues.
- Lead training of staff on technical aspects of job as required.
- Develop, revise and implement procedures that comply with appropriate regulatory requirements.
- Qualification of analytical equipment and related testing functions.
- Participate in Analytical Method Transfers
- Compliance with Standard Operating Procedures and Registered specifications.
- Ensure the laboratory is operated in a safe manner
- Maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP.
- Ensure timely completion of Laboratory Investigation Reports and deviations through the Non-Conformance procedures.
- Participate in the generation and update of SOP's, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications.
- Participate in regulatory agency inspections as required.
- Plan and implement procedures and systems to maximise operating efficiency.
- Manage and contribute to the achievements of department productivity and quality goals.
Candidates MUST have: Cell based- Bioassays, Immunoassays, Cell Culture (use of cells to execute bioassays) and Aseptic Technique
