Job
Description
Conduct in-process quality checks at various stages of manufacturing, including sampling, inspections, and testing, to ensure compliance with SOPs and regulatory requirements. Review and compile complete batch records (BMR and BPR) prior to release. Monitor steps followed in manufacturing and packing are as per standard operating procedure. Ensure all instruments are calibrated and validations are carried out in timely manner. Issue Validation Protocol, Method Validation Protocol, URS Qualification as per the schedule. Monitor critical process parameters, such as temperature, pressure, pH, and mixing times, to ensure they are within specified ranges. Review and approve batch records, manufacturing instructions, and other relevant documents to verify compliance with established procedures and specifications. Perform line clearance activities to ensure proper segregation and cleanliness of manufacturing areas, equipment, and materials. Collect and analyze samples during production runs for physical, chemical, and microbiological testing as per defined sampling plans. Withdraw stability sample control samples for analysis at intermediate and finished product stage. Issue, Review Maintain Change Control of Site, Corporate their respective logs. Issue controlled copies and retrieval of old RMS, FPS, SPS, PMS, RM PM Item Code List. Coordinate with the quality control (QC) department for timely testing and release of in-process samples. Investigate and document deviations, non-conformances, and out-of-specification results, and collaborate with the appropriate teams to identify root causes and implement corrective actions. Assist in the implementation and maintenance of quality systems, including change control, risk assessment, and document control. Support internal and external audits by providing necessary documentation and participating in audit activities. Collaborate with cross-functional teams, including manufacturing, quality assurance, and regulatory affairs, to resolve quality-related issues and drive continuous improvement initiatives. Maintain accurate and up-to-date records of all IPQA activities and documentation, ensuring compliance with GMP (Good Manufacturing Practices) and other regulatory guidelines. Identify and report the non-compliances observed in individual departments. Issue controlled copies retrieval of old SOPs and QAPs. Handling of Deviations CAPA. Handling / investigation of product complaints, incident reports, batch failures and product recalls. Preparation, Updation, issuance, retrieval of Price list. Document submission as per Regulatory requirement. Any other assignments allocated by Unit QA from time to time responsibilities Stay informed about current industry practices, regulatory requirements, and quality trends to enhance IPQA processes. Pedigree B.Pharm/ M.Pharm with minimum 1-3 Years of experience in IPQA
