Senior Executive
Location: Ankleshwar, India
Category: Quality Jobs
Company: Cadila Pharmaceuticals Ltd
Job Code: 18004876
Brand: Manufacturing - Ankleshwar
Job Status: 1
Description:
• Review analytical data of scale-up and validation batches, commercial batches of finished products, raw materials, packing materials, in-process samples, intermediates, hold time studies, stability studies, and working standards.
• Review system audit trails and electronic data, ensuring comparison of hard copies and soft copies.
• Ensure every analysis is performed as per the predefined approved/current version of specifications and methods of analysis.
• Ensure that all analyses as per customer specifications (for dispatch) are conducted as per planning and that all dispatches are completed on time with proper documentation.
• Monitor and maintain records of training, analyst validation, and competency.
• Ensure all records/documents comply with regulatory requirements.
• Ensure that all entries, records, and results align with current specifications and STPs. Review and approve certificates of analysis for raw materials, packing materials, intermediates, and APIs.
• Ensure daily online entries in SAP and LIMS modules.
• Review certificates of analysis from outside laboratories.
• Ensure CFR 21 Part-11 compliance and adherence to good chromatography practices during analysis and review for proper chromatographic data integrity.
• Ensure that all documents/records required for regulatory compliance are maintained properly.
• Review SOPs for regulatory compliance and actual practice.
• Ensure timely reporting and resolution of NQI, OOS, OOT, deviations, customer/market investigations, and change controls.
• Ensure all issues related to completed batches are resolved and documents are transferred to QA.
• Revise SOPs/STPs as per schedule.
• Maintain instrument logbooks properly as per analysis requirements.
• Ensure GLP and GMP practices are followed effectively in the Quality Control laboratory.
• Review Standard Operating Procedures, worksheets/protocols for hold time, stability, validation, qualification, and other relevant quality control documents.
• Coordinate with the QA department for cGLP system implementation.
• Coordinate with the production department for online analysis.
• Coordinate with the production department for planning and clubbing of analyses.
• Coordinate with the store department to provide prior information regarding urgent raw material analysis.
• Prepare and submit reports as required.
• Ensure the proper storage of lab chemicals and test samples with segregation to prevent accidents.
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