Quality Assurance Executive

PRIMARY

To work as per the strategic goals of the company, keeping the vision and mission of the company in mind

Documentation

New SOP generation of processes and machines

Updating of existing SOPs and formats as per DCRN sent for QA

Updating of change control and register

Updating internal failures and CAPA register

Generating final product specifications, raw material, and packaging good specifications along with MSDS as per requirement

Review of processes, SOPs and formats sent by departments

Maintain documents as per ISO/Quality management system

Execution

Line clearance of sterile PDN as per plan

Screening of sterile RTU products and their reconciliation

Record the observations/deviations/incidences which are not followed during production (as per SOP/Process) and inform to Sr. QA Manager.

Approval of raw material and packaging goods results

Approval of water testing results

Approval of environmental monitoring results

Approval of finished good labels

Take action on major observations/deviations/incidences by initiating CAPA

Coordination of results with QA and handover of product to labelling

Review of BMR and submission to the Sr. PDN and Sr.QA Manager for final review as per GDP

Ensure Raw material and packaging return after production

Ensure the product quarantine as per the status

Response to the internal coordination emails

In case out of specification, ensure the product is moved to rejection area and coordinate with Sr. PDN and QA for actions

Closure of CAPA and OOS

Generate product specification sheets

Issuance of documents required for labelling and production

PRIMARY

To work as per the strategic goals of the company, keeping the vision and mission of the company in mind

Documentation

New SOP generation of processes and machines

Updating of existing SOPs and formats as per DCRN sent for QA

Updating of change control and register

Updating internal failures and CAPA register

Generating final product specifications, raw material, and packaging good specifications along with MSDS as per requirement

Review of processes, SOPs and formats sent by departments

Maintain documents as per ISO/Quality management system

Execution

Line clearance of sterile PDN as per plan

Screening of sterile RTU products and their reconciliation

Record the observations/deviations/incidences which are not followed during production (as per SOP/Process) and inform to Sr. QA Manager.

Approval of raw material and packaging goods results

Approval of water testing results

Approval of environmental monitoring results

Approval of finished good labels

Take action on major observations/deviations/incidences by initiating CAPA

Coordination of results with QA and handover of product to labelling

Review of BMR and submission to the Sr. PDN and Sr.QA Manager for final review as per GDP

Ensure Raw material and packaging return after production

Ensure the product quarantine as per the status

Response to the internal coordination emails

In case out of specification, ensure the product is moved to rejection area and coordinate with Sr. PDN and QA for actions

Closure of CAPA and OOS

Generate product specification sheets

Issuance of documents required for labelling and production

Control of labelling and packaging

Line clearance of labelling and packaging as per plan

Approval of labels

Complaints and Feedback

Handle and take action (CAPA) of customer complaints and feedback in coordination with senior

Audit:

Initiate actions related to points observed during internal and external audit

Calibration and Validation

Coordinate calibration and validation activities scheduled with production and third-party vendors as scheduled

Generate validation protocol and report of the equipment’s and processes

Training

Give training to production employees

HSE

Health, Safety and Environment compliance

Idea Generation

Generate and implement new ideas to make the current process better

Job Type: Full-time

Pay: ₹15,006.49 - ₹30,000.00 per month

Benefits:

• Food provided
• Paid sick time
• Provident Fund

Work Location: In person

Speak with the employer
+91 8655704652