Sr. Manager- Quality Assurance (QA QC)

Job Description:

Sr. Manager- Quality Assurance (QA QC)

Job Responsibilities?:- 

• Planning and execution of daily QA, QC operation activities for production in Injectable section to smooth Functioning work culture. 
• To prepare and review the   SOPs of QA QC departments. Ensure qualification/ validation status of equipment’s  
• QA, QC of Internal and external Manufacturing as per SOP. 
• Experience of handling the QMS (Quality Management System) section in absence of section in charge and also handling the team related to work distribution and monitoring of all activities of QMS section. 
• Train team for WHO GMP standards  
• Modify and apply procedures wherever required to reach who GMP standard 
• Able to prepare weekly/monthly Production planning, availability of Raw Materials and Packing Materials. 
• Confirming safe and efficient working conditions as per GMP guidelines. Preparation and implementation of SOP’s as per current Good Manufacturing Practices. 
• Production process developed and establishments. 
• Should have enough knowledge & work experience of validation & qualification procedures for processes, personnel and cleaning activities. 
• Checking of batch documents, master documents and process or system related other daily records of production area. 
• Adequate knowledge of utility system for Parental products handling.  
• Timely completion of the process jobs to ensure smooth production working system. 
• Ensure that all production schedules perform as per production planning. 
• Plan and monitor the activities in the laboratory by reviewing the status of batch release and related activities to meet the regulatory requirements with respect to lead team, quality service. 
• Monitor the implementations of Quality environments as per SOPs to ensure compliance to cGMP, GLP, GxP and regulatory requirements. 
• Preparation and review of validation protocols, reports, apex documents, and departmental SOPs. 
• To ensure that products are manufactured in compliance with cGMP requirement. 
• To monitor, track arrange for the equipment, utility, process, cleaning, vendor and other qualification/validation related activities. 
• Monitoring of validation activities. 
• Prepare and review of validation master plan. 
• Reviews of executed validation document for equipment’s, media fill, utility, HVAC, water system. 
• Ensure the final checking of the finish product before releasing the batch. 
• To review the Qualification / Validation protocols / report for equipment qualification / process validation / cleaning validation. 

Reports / Reporting: 

• Send daily/weekly/monthly inquiry reports Authorized Person 
• Send weekly/monthly action plan to Authorized Person. 
• Send Monthly achievement data to Authorized Person. 
• send weekly activity report to Authorized Person. 
• Send monthly Lab needed report. 

Job highlights 

• Overall QA QC function. 
• Ensure the quality of the product at each step starting from entry of raw material to exit of finished goods.  before releasing the batch. 
• Review of the BMR / BPR Filled by the Production before final release of the product and final checking of the finished product before releasing the batch             .      for dispatch. 
• To ensure that product is manufactured in compliance with cGMP requirement. 
• Internal quality / process/Product / Customer/QMS Certification audit. 
• Person should have experience of working in microbiology department of QC. 

Required Candidate profile:  

1. Sc. Microbiology / B. Pharma  

Experience : Minimum 15- years (Injectables Industry). 

Skills:

Business Analysis. Data Analytics. Product Quality. Quality System. Quality Assurance & Quality Control. Data Management. Quality Management. 

Laboratory: Micro pharmaceuticals. Good Laboratory Practice (GLP)