Position Description : Position ensures that the products provided to the market are tested as per customer specifications and in compliance with applicable pharmacopoeias as well cGMP/GLP/ICH/USFDA/ISO guidelines. Key Responsibilities: Analysis of Finished products / raw materials/ in process & stability samples (Wet & Instrumental analysis). Preparing stability trend and then sharing with all stake holders. Conducting LSC to update all stake holders on stability status. Calibration of HPLCs as per defined procedure and schedule. Method validations as per applicable guidelines. Inventory management of reagents/columns spares etc. required for Premix analysis. Mobile phase preparation and their record keeping. Printing and preparation of record of analysis. Log books management for various activities. Preparation/Revision of method of analysis. Revision/Preparation of specifications in consultation with Purchase and other departments. Reporting of deviations in analysis as per LIR procedure and implementation of CAPA. Day to day handling of hurdles for smooth analytical work (Trouble shooting of instruments). To ensure good housekeeping in the working area as well as in surroundings. Conducting of stability studies of Premix for validation batches/Annual batches. To ensure compliance to all SHE guidelines and to ensure safe working. Requirements: Post-Graduation in Chemistry. Knowledge of cGMP & GLP guidelines, ICH/ USFDA guidelines. Working knowledge of Method development and validation. Handling of instruments like HPLC/GC/GCHS/Spectrophotometer etc. Minimum 6 years of experience in Pharmaceutical industry and extensive Quality control experience in API manufacturing industry.
Position Description : Position ensures that the products provided to the market are tested as per customer specifications and in compliance with applicable pharmacopoeias as well cGMP/GLP/ICH/USFDA/ISO guidelines. Key Responsibilities: Analysis of Finished products / raw materials/ in process & stability samples (Wet & Instrumental analysis). Preparing stability trend and then sharing with all stake holders. Conducting LSC to update all stake holders on stability status. Calibration of HPLCs as per defined procedure and schedule. Method validations as per applicable guidelines. Inventory management of reagents/columns spares etc. required for Premix analysis. Mobile phase preparation and their record keeping. Printing and preparation of record of analysis. Log books management for various activities. Preparation/Revision of method of analysis. Revision/Preparation of specifications in consultation with Purchase and other departments. Reporting of deviations in analysis as per LIR procedure and implementation of CAPA. Day to day handling of hurdles for smooth analytical work (Trouble shooting of instruments). To ensure good housekeeping in the working area as well as in surroundings. Conducting of stability studies of Premix for validation batches/Annual batches. To ensure compliance to all SHE guidelines and to ensure safe working. Requirements: Post-Graduation in Chemistry. Knowledge of cGMP & GLP guidelines, ICH/ USFDA guidelines. Working knowledge of Method development and validation. Handling of instruments like HPLC/GC/GCHS/Spectrophotometer etc. Minimum 6 years of experience in Pharmaceutical industry and extensive Quality control experience in API manufacturing industry.
To ensure that the Products provided to the market are tested as per Customer specifications and in compliance with applicable pharmacopoeias as well cGMP/GLP/ICH/USFDA /ISO guidelines. Key Responsibilities: To participate in vendor qualification activities. To participate in Internal/External audit activities To ensure compliance as per applicable regulatory requirement. Release/rejection of finished products, intermediates & raw material as per approval specification Creation & release of Certificate of analysis. Issuance and review of Batch production records. QC analytical data review. Handling sales return, recalls and compilation of APR data To coordinate investigation of market complaints/deviation/OOS/OOT. Log books management for various activities. To ensure that sampling of all Finished products are done as per defined procedure and proper record is being kept compliance to cGMP practice. To ensure compliance to all SHE guidelines and to ensure safe working. Conducting monthly safety audit and ensuring the closures of observations. Reporting of Near misses/Incidents. Ensuring that all SHE related guidelines/rules are followed while doing any activity to achieve the goal of SAFE place to work. Clearance of safety work permits to ensure execution of activities in safe manner. To release the Batches of Intermediates and Finish goods in SAP. Requirements: Post-Graduation in Chemistry having knowledge of cGMP & GLP guidelines, ICH/ USFDA guidelines. Knowledge of documentation related to quality and regulatory guidelines. Minimum 9 years of experience in Pharmaceutical industry and extensive Quality Assurance experience in API manufacturing industry.