Title: Manager

Date: May 5, 2025

Location: Baddi - Quality Assurance

Company: Sun Pharmaceutical Industries Ltd

Job Summary:

The position is responsible for Investigation, Compliance and Improvement in Quality System at site through Quality Management Tools to ensure the Quality of Products Manufactured and released from site to India and Export market.

Essential Job Functions:

Responsible for:
To ensure that Deviations, OOS/OOT & Product Quality complaints are documented and Investigated thoroughly within defined timelines & to participate in investigations.
To ensure that Investigations for Deviations, OOS/OOT & Product Quality complaints are concluded with scientific rational and effective Corrective & Preventive actions are implemented.
To ensure that final market release of drug product(s) lot(s)/batch (es) while an Investigation is still in progress is not permitted.
To ensure investigations for which root cause could not be identified shall be approved by the Site Head of Quality via Quality Approver role. The product disposition associated with such investigation shall be also approved by the Site Head of Quality.
To ensure Investigation records shall not be closed by creating an Action Item / Task / CAPA record for pending investigation elements.
To ensure if human error is suspected as primary root cause during investigation, further assessment shall be carried out in order to expand the root cause categories and identify the underlying cause so as to eliminate the event from recurring.
To ensure that Change controls are having proper justification for proposed changes and are evaluated and approved before implementation.
Review and approval of QMS documents (Deviations, Change Control, PQC, OOS/OOT, Lab events, CAPA, UAM, Artworks/shade cards etc.).
To ensure that Management Notifications related to critical Market complaints, Deviations & OOS in Stability samples are raised and closed timely.
To ensure timely initiation of Product Recalls in line with SOP on Recall Process Management.
To Lead the assessment, tracking of remediation and monitoring of identified actions as a part of various Corporate initiatives.
To ensure that trends for QMS activities are prepared timely and corrective & preventive actions are taken for adverse trends.

To ensure timely handling of Notifications from Regulatory agency regarding Samples for Genuineness

Job Summary:

The position is responsible for Investigation, Compliance and Improvement in Quality System at site through Quality Management Tools to ensure the Quality of Products Manufactured and released from site to India and Export market.

Essential Job Functions:

Responsible for:

To ensure that Deviations, OOS/OOT & Product Quality complaints are documented and Investigated thoroughly within defined timelines & to participate in investigations.
To ensure that Investigations for Deviations, OOS/OOT & Product Quality complaints are concluded with scientific rational and effective Corrective & Preventive actions are implemented.
To ensure that final market release of drug product(s) lot(s)/batch (es) while an Investigation is still in progress is not permitted.
To ensure investigations for which root cause could not be identified shall be approved by the Site Head of Quality via Quality Approver role. The product disposition associated with such investigation shall be also approved by the Site Head of Quality.
To ensure Investigation records shall not be closed by creating an Action Item / Task / CAPA record for pending investigation elements.
To ensure if human error is suspected as primary root cause during investigation, further assessment shall be carried out in order to expand the root cause categories and identify the underlying cause so as to eliminate the event from recurring.
To ensure that Change controls are having proper justification for proposed changes and are evaluated and approved before implementation.
Review and approval of QMS documents (Deviations, Change Control, PQC, OOS/OOT, Lab events, CAPA, UAM, Artworks/shade cards etc.).
To ensure that Management Notifications related to critical Market complaints, Deviations & OOS in Stability samples are raised and closed timely.
To ensure timely initiation of Product Recalls in line with SOP on Recall Process Management.
To Lead the assessment, tracking of remediation and monitoring of identified actions as a part of various Corporate initiatives.
To ensure that trends for QMS activities are prepared timely and corrective & preventive actions are taken for adverse trends.
To ensure timely handling of Notifications from Regulatory agency regarding Samples for Genuineness Verification and NSQ Samples received from Drugs Control Authority.
To support the internal audit/CQA/Regulatory audits.
Monitoring and tracking of various compliance actions which arises due to regulatory inspections & internal\customer audits.
To escalate pending issues related to QMS to site Leadership for timely resolution.
Any other work assigned by QA Head & Quality Head.