Job Responsibilities
- 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
