SENIOR Q.C. ANALYST

Job Description

Purpose:

To ensure that analyses and other duties assigned on the basis of the daily plan are performed in compliance with their respective procedures and other guidelines.

Main responsibility/activity areas:

A. Analyses

• To analyse raw materials, intermediate products, in-process products, finished products, and stability samples using all necessary test instruments available in the laboratory, according to the methods indicated in internal procedures.
• To perform method validations / method transfers / method development as required

B. Coaching

• To coach staff on new methods being developed and other transfer methods if required
• To assist the Validation Senior Analyst with analytical method validations and transfers.
• To help with analytical/technical problems of the analysts if required
• To provide support to the regulatory department in developing new methods and other analysis if required
• To provide support on troubleshooting with analysis
• To provide support to the analysts and other senior analysts, QC lab supervisor and QC Manager as required

B. Lab Instruments

• To keep equipment and test instruments used in good condition.
• Problem solving of instruments within the boundaries of one’s competence

C. Documentation

• To keep updated all documentation in relation to analyses made, with their respective raw data attached thereto.
• To keep the laboratory documentation and his own documentation in good order.
• To review data related to analysis performed by the analysts, if required
• To write the protocols and reports related to the method validations or method transfers as requested

D. Good Housekeeping

• To keep workplace clean and well organized.

E. Others

• To collaborate in the introduction of new analytic methodologies, optimizing the existing ones, and in analytic validations.
• To report to superiors any abnormalities found during routine activities and autonomously correcting routine analytic problems.
• To participate in training courses on Safety, Quality, and Environment.
• To propose improvements to the management process for the activities falling under his competence.

and any other duties as may be requested by the Company from time to time.

F. Back up

• Senior analyst

Shift Work

• The senior analyst is expected to work on a shift basis