Senior Executive/Executive, QC @NOVO Healthcare & Pharma Ltd.

Job Description / Responsibility

• Performs analysis of all laboratory samples including raw material, in-process, finished products, purified water, process, method and cleaning validation and stability samples using analytical instruments and established analytical procedures and techniques.
• Prepares test samples and sets up and operates various laboratory instrument.
• Performs analyses associated with method transfer and/or method verification.
• Documents, interprets, and compiles all observations and data obtained from testing as per established SOPs and good documentation practices.
• Recognizes OOS or out of trend results and completes lab investigations under minimum supervision. Promptly notifies Supervisor of any observations or results, which may impact on the validity of data and/or reflect variability in the manufacturing process where applicable.
• Performs general maintenance and calibration of laboratory equipment as required by the department’s established calibration program and GMP requirements.
• Troubleshoots instrumentation and method problems, recommends solutions and works collaboratively with Supervisor to resolution.
• Utilizes technical expertise to troubleshoot on more complex, problematic products.
• Performs all work in accordance with all established regulatory and compliance and safety requirements.
• Disposes of waste solvents and orders any chemicals or laboratory supplies as required.
• Performs role of document reviewer as outlined below:
• Reviews electronic and/or paper data of non-conformance.
• Reviews calibration of instruments, as assigned, to ensure accuracy and precision in the performance of laboratory equipment.
• Reviews third party documentation, method transfer projects and supplier certificate of analysis, as applicable, to ensure completeness and accuracy of reporting.
• Liaises with department skilled personnel to ensure that all necessary corrections are made to analytical reports and document requirements to ensure compliance to GMPs.
• Works as a member of a team to achieve all outcomes.
• Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values.
• Performs all work in accordance with all established regulatory and compliance and safety requirements.
• All other duties as assigned.