Sample Management Lead

4 weeks ago

Odhav, India NEXUS CONSULTING SOLUTIONS Full time

Essential Duties and Responsibilities: This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned.

Quality:

- Handling of sample management for Finished product & API (Sample receiving,

reconciliation and destruction).

- Compiling the data for finished product.

- To generate the certificate of analysis as per requirement.

- To understand the project in the guidance of Sub-department Manager and follow their

instructions.

- To complete the planned work in the stipulated time frame, inform the Sub-department

manager if any deviation or issues observed.

- To keep track of each activity related to sample management, product analysis and

development activities.

- To make sample entries in respective logbooks.

- To follow Good Documentation Practices.

- To update the Development stability compilation sheet after the review of the ELN.

- To investigate if any deviation / abnormal observation in term of results and report to Sub-

department Manager.

- To keep the status of daily work and report to Sub-department manager on daily basis.

- To use standard formats for documentation.

- To update the GLP as per Laboratory requirement as per guidance by Sub-department Manager.

- To list all resources required for the study and keep track of routine requirements and ensure

timely procurement of the same, verify the materials received for analysis from supplier as per

given requirement.

- To complete the training as per the quality matrix targets.

- To prepare and update the SOPs.



Administrative: · To perform the work as allocated by Sub-department Manager. · To liaise with customers, staff and suppliers. · To write / fill the record in legible writing. · To keep the documentation online and on time. · To compile required data for Management Information System and provide to Sub-department Manager. · In the absence of Officer, Sub-department Manager will ensure his roles and responsibilities. Communication to the management / superiors: · To communicate samples receiving related issues to Sub-department Manager and follow the action plan. · To keep the status of daily work and report to Sub-department Manager on daily basis.


Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.

N/A: Intern or Co-op


· Bachelor / Master's in Science with 3-5 years of experience.


Key technical skills:

· Knowledge of Good Laboratory Practice and Good Documentation Practices

· Basic Knowledge of Chemical Analysis

· Knowledge of pharmacopoeia, ICH Guidelines


Key behavioral attributes:

· Communication skills

· Presentation skills

· Analytical skills

· Lateral coordination

· Positive Attitude

· Policy compliance

· Documentation Skills

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