Job Summary

The position is responsible for heading the Quality Assurance function in NOSD Parenteral Block at Sun Pharma laboratories Limited, Guwahati

Responsible to set the team goals and objectives for the NOSD Quality at Guwahati site in alignment with goals of Cluster Quality and other business function(s).

Responsible to collaborate and support to functional heads of QA, QC, Microbiology, Production, IT, Regulatory Affairs and commercial department to align organizational goal and business strategies for achieving overall quality.

Responsible for providing guidance to ensure achievement of targeted completion of tasks and execution of team.

Responsible for facilitate harmonization and consistent implementation or Quality Systems and procedures (Pertaining to parenteral), in alignment with Global Quality Policies, Standards and applicable SOPs.

Essential Job Functions: Primary Responsibility:

Review and monitoring of Quality operations at Parenteral Block.

To execute, monitor, review, and approval of Quality management systems i.e. Change control, Deviation, and CAPA management as per requirements.

To review and approve Standard Operating Procedure etc.

To ensure the compliance of documentation at various stages of the process i.e. (Manufacturing, Filtration, Filling, Visual Inspection, Labelling and Packing operations).

To review, approve the Master and executed BMR, BPR, Validation, Qualification and other GMP documents.

To evaluate and monitor the Aseptic process simulation (Media Fill) activities with respect to the APS planner, Trending of intervention protocol & reports.

To facilitate harmonization and consistent implementation of the quality systems and procedures at the site in alignment with corporate quality policies /procedures.

To review, update, respond to GQS/Regulatory audit observations within the stipulated time frame.

To participate in the review & approval of investigation in case of Non- conformance events i.e. Process Deviation, OOS, OOT & Product Quality Complaint.

To ensure release, approval, or rejection of Raw Material, Packing Material, Intermediate, Finished products as per approved specifications.

To ensure completion and implementation of CAPA as per established procedure and follow up to verify the effectiveness of CAPA.

Responsible for the batch disposition (Batch release or reject).

To ensure compliance of electronic systems such as manufacturing equipment/instruments etc.

To ensure equipment /instrument, qualification/calibration and prevent maintenance are performed as per approved planner.

To ensure that processing and storage area are qualified as per the approved procedure and GMP requirements.

To impart training to the plant personnel as per requirement and ensure the effectiveness.

To be part of self-inspection and or quality audits that regulatory appraises the effectiveness and applicability of the quality system as per schedule.

To ensure and perform work as per established approved procedure, regulatory norms and its compliance as per the current regulatory requirement.

Facilitate/support the implementation of new initiatives of Corporate functions at site.

Secondary Responsibility

Specific emerging projects as applicable.

Perform any other responsibility assigned by the Quality Head/Management.