Required Experience : 5 - 6 Years

Job Summary

Globela Pharma Private Limited is looking for an experienced and detail-oriented Quality Control (QC) professional to manage day-to-day QC laboratory operations, ensure compliance with cGMP and cGLP requirements, review analytical data and documentation, and support the timely release of raw materials, packaging materials, bulk products, in-process samples, semi-finished products, finished products, and stability samples.

The candidate will be responsible for maintaining data integrity, ensuring laboratory compliance, supervising QC analysts, managing laboratory documentation, and supporting digital implementation through PC-360 software.

Key Responsibilities1. QC Laboratory Operations and Team Management

- Manage the opening and closing of the QC department and ensure adherence to company working hours and HR policies.
- Prepare monthly shift schedules and distribute work among QC analysts in the absence of the QC Manager.
- Monitor daily sample receipt, analysis, and reporting activities for RM, PM, bulk, in-process, semi-finished, finished product, and stability samples.
- Guide QC analysts in routine analytical activities and provide troubleshooting support when required.
- Ensure proper discipline, personal hygiene, and housekeeping practices within the QC laboratory.
- Conduct on-the-job training and ensure analyst qualification, training evaluation, and training records are maintained.

1. Analytical Data Review and Product Release

- Review specifications, standard analytical procedures, raw data sheets, analytical worksheets, and related documentation for RM, PM, bulk, in-process, semi-finished, and finished products.
- Review instrumental analysis data and analytical reports to ensure compliance with approved specifications and procedures.
- Review and release materials and products in the ERP system, including COA preparation or verification, wherever applicable.
- Review external laboratory analytical reports and raw data to ensure compliance with specifications and applicable requirements.
- Monitor daily water testing activities and review the associated records.
- Review stability study data, reports,



and schedules; coordinate stability activities in the absence of the designated stability analyst.
- Review R&D; and miscellaneous sample receipt, analysis, and related records.

1. cGMP, cGLP and Data Integrity Compliance

- Ensure day-to-day compliance with current Good Manufacturing Practices (cGMP), current Good Laboratory Practices (cGLP), company procedures, and applicable regulatory requirements.
- Monitor data integrity across QC documentation, analytical records, logbooks, and electronic systems.
- Review audit trails and ensure records are maintained according to approved SOPs.
- Identify and report abnormalities, discrepancies, and compliance issues to the QC Manager and QA Manager.
- Ensure daily review of laboratory temperature and humidity records, cleaning records, instrument calibration and verification records, and other applicable documents.
- Maintain accurate, complete, and contemporaneous documentation of laboratory activities.

1. Quality Management System (QMS)

- Review and monitor Out-of-Specification (OOS), Out-of-Trend (OOT), deviations, incidents, and change controls related to the QC section.
- Support investigations, corrective and preventive actions, and implementation of approved quality system procedures.
- Review and maintain laboratory logbooks, worksheets, analytical records, and other controlled documents.
- Prepare for internal, external, customer, and regulatory audits and support documentation updates as required.
- Ensure proper maintenance and retention of laboratory records in accordance with approved SOPs.

1. Instrumentation and Laboratory Equipment

- Monitor instrument calibration, verification, and preventive maintenance schedules.
- Prepare and monitor calibration and preventive maintenance planners and maintain the associated records.
- Review analytical and cleaning method validation protocols,



execution records, and reports.
- Support validation activities, including Analytical Method Validation (AMV), process validation (PV), and cleaning validation (CV), as applicable.
- Assist analysts with troubleshooting during instrumental analysis and ensure equipment is used according to approved procedures.

1. Laboratory Materials and Reference Standards

- Monitor the preparation, standardization, re-standardization, usage, and documentation of working standards, reference standards, primary standards, and volumetric solutions.
- Monitor laboratory chemical inventory, procurement requirements, stock levels, and associated records.
- Ensure proper maintenance of records for the receipt, analysis, and destruction of leftover QC samples after completion of analysis.

1. Digitalization and Process Improvement

- Support the implementation and effective use of PC-360 software for digital working in the QC department.
- Train and guide QC personnel in the use of PC-360 and related digital systems.
- Ensure accurate electronic documentation and adherence to applicable data integrity and audit trail requirements.

1. Reporting and Coordination

- Report daily QC activities, analytical observations, discrepancies, and compliance issues to the QC Manager and QA Manager.
- Coordinate with QA, Production, Warehouse, R&D;, and other relevant departments to ensure smooth laboratory operations.
- Perform QC sample analysis, validation studies, and other laboratory activities as assigned by superiors.

Secondary Responsibilities
- Prepare and execute Analytical Method Validation (AMV) protocols for raw materials and finished products.
- Assist in the preparation and monitoring of calibration and preventive maintenance schedules.
- Perform routine and validation analysis as required.
- Support process validation, cleaning validation, and instrument calibration activities.
- Provide technical guidance to analysts during routine and instrumental analysis.
- Review and monitor R&D; and miscellaneous sample analysis and documentation.

Pay: ₹300,000.00 - ₹500,000.00 per year

Perks

- Provident Fund

Work Location: In person

📌 Quality Control (QC) Executive / Senior QC Officer (Sachin)
🏢 Globela Pharma
📍 Sachin