Job description

Analytical Method development/ qualification

Assist the team leader in conducting literature survey by reviewing documents such as pharmacopeia, research available in public domain
Conduct analytical procedures by following the trial and error methodology prescribed by Team Leader to assess the workability of the proposed analytical method
Conduct method qualification activities based on protocols

Analytical Method Validation and Method Transfer as per cGMP

Perform the validation exercise as per work plan (in accordance with protocol).
Report any discrepancies in the results to the Team Leader, in a timely manner
Assist in preparation of Standard Analytical Procedures (SAP) document.
Conduct/ perform the method transfer at the plant by guiding the plant QC and investigate concerns if any
Maintain appropriate consumption record of working & reference standards and intimate Team Leader in case of low availability
Generate standards by doing sample analysis/characterization and preparing analytical data sheet

Regulatory and compliance

Record the raw data contemporaneously (as it happens) in form of observations/reports and communicate to the TL
Adhere to regulatory, cGMP, SOPs and safety guidelines for all processes
Calibrate all instruments as scheduled
Prepare instrument related Standard Operating Procedures (SOPs) by gauging workability of the processes/practices in timely manner
Ensure data integrity in all respects
Conduct specified tests and prepare relevant documents to aid team leader in resolving internal/external audit and regulatory queries, whenever required
Initiate incidence investigation and change controls
Ensure audit preparedness and provide support in audit and/or related activities as and when required.

Development and stability analysis and other testing related activities

Conduct analysis of development samples as per the method being developed, aid in populating the PDR by conducting tests and preparing analytical data sheet to formalise the method
Conduct analysis of pilot batch samples as per the method
Conduct stability analysis by packaging, recording, charging the samples as per schedule and preparing reports to aid DDRL/
Enable vendor qualification by conducting analysis by following COA provided by the vendor and flagging off if discrepancies are found
Conduct specialized tests like GC, MASS SPEC, CD, CE etc. as required
Conduct basic troubleshooting of instruments as and when required

Carrer Innovater