Analyst / Senior Analyst

POSITION SUMMARY

This role is responsible for technical laboratory activities in support of client studies or procedures. He/She will perform analysis of data for quality and completeness and determine if results are as expected. He/She will be responsible for recording of data in compliance with company and regulatory policies and standards to meet quality and accuracy requirements, and ensuring compliance with protocols and all applicable SOPs.

DUTIES & RESPONSIBILITIES

. Performs all laboratory functions as tasked with high degree of accuracy and strict adherence to Company's quality requirements.

. Maintains proper records that are compliant with good documentation practices (GDP) and data integrity requirements, for all testing and test-related activities (e.g. raw data sheets, usage log books, and all other records).

. Generates reports for all tests performed in an accurate and timely manner, ensuring that targets are met for accuracy and turnaround time.

. Performs good housekeeping and maintenance of the laboratory, especially in the area of responsibility.

. Prepares client test protocols, facilitates training of other analysts for the approved client test protocols, and updates protocol database.

. Generates or revises standard operating procedures (SOPs) relating to area of responsibility during routine document review or when there is a regulatory update.

. Participates in investigations (e.g. root cause analysis, impact analysis, risk assessment, corrective action, etc.)

. Contributes significantly to the activities of the assigned technical committee, as per the duties and responsibilities designated to the committee.

. Provides support during external and internal audits for the areas of responsibility.

. Actively seeks improvement within area of responsibility and takes necessary action to implement such improvements.

. Participate in method development and validation of routine and customised testing services.

. Participate in the establishment of customised routine testing services and validations that are in compliance with the latest regulatory and/or customer requirements.

. Conducts test demonstrations to clients during site visit or when necessary.

. Documents and reports to immediate superior any event that has occurred at the laboratory which could, in his/her reasonable opinion, potentially result in a hazardous, litigious or quality-compromising situation.

. Adheres to Company Policies and Procedures.

. Ensures relevant Health and Safety requirements are adhered to, including undertaking any mandatory training as required.

. Undertakes any other duty or responsibility, at the request of your manager that may be required within reason within the remit of your role.

General requirements

. Maintains confidentiality of all Client information according to internal SOPs, Quality Service Agreements, and regulatory requirements.

. Actively seeks improvement within area of responsibility and takes necessary action to implement such improvements.

. Adheres to Company Policies and Procedures, including Code of Ethics and to Health and Safety requirements.

. Performs all other related duties as assigned.

QUALIFICATIONS:

. Bachelor of Science or any related field Diploma in related field would be considered.

. Minimum 2 years of relevant QC microbiological experience working in an ISO17025 / GMP laboratory environment

. Good knowledge of ISO 17025, cGMP and other regulatory guidelines

. Good technical understanding and judgement

. Good interpersonal and communication skills across cultures

. Team player with ability to work in cross-functional teams as well as independently depending on requirement of task on hand