Manager

Purpose

The candidate shall have the role of Reviewer in analytical development lab to support pharmaceutical formulation development i.e., Solid/ Liquid oral products.

Position / Job Title

Manager

Department

Analytical Department

Reporting To

GM Analytical Method Validation and RM/PM

Location

Thane

Years Of Experience

>10 yrs

Dosage Form

Active Pharmaceutical Ingredient

Job Responsibilities / Deliverables

To guide and review method development activities for API or raw materials tests using HPLC and other techniques .

Alignment of raw material team activities and documentation work as per organization priorities.

Review of API DMF and communication with API supplier for DMF/spec related queries.

Review of method evaluation reports for API and excipients.

Responsible for successful API method transfer activities to QC lab.

Paper assessment and analytical evaluation of alternate source API, excipients, packing materials.

Review of Mfg. COA for new drug substances and excipients.

Interaction with AMV team for smooth functioning of raw material method verification and arrangement of pre-requisites for API method verification.

Ensure the availability of resources to execute the analytical work and availability of documents to QC.

Inputs to be provided for material budget preparations.

Support to FDA deficiencies related to raw material analytical and documentation support.

Preparation of presentations for stage gate, AD –QC meeting.

Communication and meeting with QC to resolve concerns related to raw materials.

Provide inputs / feedback on current status of the project to supervisors/cross functional teams.

Liasion with external testing labs for outsourced testing.

Aligning team activities to meet organisational targets

Monitor adherence of GLP compliance by team members

Review various documents like Method of analysis/method validation protocol/validation reports/method transfer reports, AMDR etc.

Periodic updation of SOPs related to functional area.

Providing technical inputs for method development, resolving issues, etc.

Conduct testing of batches as per plan and provided targets.

Review of laboratory notebooks, analytical raw data and electronic data

Responsible for compliance with all internal audits and customer audits.

Perform investigations related to deviations/incidences and recommend CAPA as required.

Qualifications & Pre-Requisites

M. Pharm/M. Sc

Knowledge of handling HPLC, GC and other analytical techniques.

Exposure to API method verification/validation and testing

Additional Notes

Candidate is expected to work in all shifts.

Candidate is expected to visit external sites as per projects requirements.