QA Sterile Supervisor

Role Overview

This position is for a QA Sterile Supervisor within the Global Quality & Compliance function at Sun Pharma, based in Dewas, Madhya Pradesh. The role is positioned at Senior Officer / Executive level and is focused on quality assurance support for sterile and manufacturing operations, with strong emphasis on compliance, documentation, sampling, investigations, and quality system execution.

Sun Pharma describes its work environment as one that encourages continuous growth, ownership, collaboration, and steady improvement.

Core Responsibilities

• Oversee in-process quality assurance activities in the Penem manufacturing block.
• Ensure that all plant operations follow cGMP expectations.
• Collect samples of rinse water, purified water, water for injection, pure steam, intermediates, and finished goods.
• Track API and formulated products to confirm they are maintained under the conditions specified in the batch production record.
• Monitor sampling and quality checks during filling and packing operations.
• Issue, control, and retrieve logbooks as required.
• Certify batch production records after verifying compliance and stage-wise completion.
• Perform line clearance, in-process checks, and coding approvals across manufacturing and packaging stages.
• Monitor beta-lactam containment practices across blocks.
• Support preparation of annual product review and annual product quality review documents.
• Manage collection, review, and handling of control samples for API and finished products.
• Carry out calibration of IPQA laboratory instruments.
• Prepare, initiate, review, issue, and retrieve SOPs.
• Support deviation handling, market complaint investigations, and related reviews.
• Review and approve master batch records, including FO/MI and PO/PI documents.
• Review and approve qualification protocols and reports for equipment.
• Review and approve process validation protocols and reports.
• Ensure contamination control measures are implemented and followed according to the Contamination Control Strategy and applicable procedures.
• Track the timely start and completion of workflow steps for all TrackWise records.
• Review change proposals for quality impact, stakeholder selection, classification, required actions, closure of actions, and approvals at the right stages.
• Review and close deviations, including investigations related to deviations, OOS, OOT, and excursions in environmental monitoring and water sampling.
• Provide support during validation and qualification studies.
• Manage stability samples for finished goods.
• Handle required SAP transactions.
• Complete all mandatory LMS trainings within assigned timelines.
• Manage archival, retrieval, storage, and destruction of cGMP documents.
• Identify training needs for different roles, prepare the master training matrix, assign training activities, maintain trainer qualification logs, monitor pending training, ensure training completion, maintain manual training records, upload records into LMS, and review training certifications for new employees.
• Carry out detailed investigations with production teams for complaints, deviations, OOS, and stability failures, including root cause analysis, corrective and preventive actions, and timely closure.

Experience

The role calls for 5 to 8 years of relevant experience.

Important Notice

The employer notes that this job summary is intended to describe the general nature and level of the role. It is not a complete list of all duties, responsibilities, or qualifications, and responsibilities may change over time as needed.

About Sun Pharma

Sun Pharma emphasizes a culture of continuous improvement, personal ownership, teamwork, and long-term growth for its people.