Nexus Pharmachem Pvt. Ltd.

Naroda, Ahmedabad

Job descriptionMonitor/verify qualification of Machine before putting in operation. SOPs, BMRs, MFRs Strict implementation. Process validations calibrations of control equipment performed recorded knowledge of reactor operation, centrifuge, ANFD, RCVD, sparkler filter.Handling Instrument and Knowledge Glass Assembly, Reactors, Centrifuge, Nutsche Filter , Hot Air Dryer , Vacuum Tray Dryer, etc...1. Supervising daily, weekly & monthly production as per the guidelines2. Managing Manpower according to the production planning in the concerned shifts.3. Assisting Asst. Production managers in all the work4. Training of all Supervisors & Junior Production Chemist to prepare the monthly reports5. Maintaining all B M R online.6. In Process sampling / Testing of all materials.7. Making & updating all the records, register, documents as per the SOP8. Daily calibration of all equipment as per the schedule9. Preparing weekly shift report10. Maintaining all equipment log books i.e. Dryer, Reactor, CF etc..11. Maintaining Status label at all times on all equipment process and in process material.12. Monitoring and maintaining all equipment in the Production area including, Housekeeping, Safety, Packing and other miscellaneous equipment.13. Following the GMP guidelines in the production.14. Updating & coordinating with the Engineering Department for any breakdowns and Preventive maintenance.15. To follow Nexus Pharma and QUALITY policy at all times.16. Any other associated work assigned to you from time to time.Role: ChemistIndustry Type: Pharmaceutical & Life SciencesDepartment: Production,ManufacturingEmployment Type: Full Time, PermanentRole Category: Operations, Maintenance & SupportEducationUG: B.Sc / B.Pharm , BE Chemical in Any SpecializationPG: M.Sc (Science)/ M. Pharm in Any Specialization

Review and update standard operating procedures (SOPs) to align with changing regulations and best practices. Documentation And Records Management- Maintain and manage documentation related to quality assurance activities, including batch records, investigation reports, change controls, and validation documentation.- Ensure accurate and timely completion of all quality-related documentation. Product Quality Control- Investigate product non-conformances, deviations, and customer complaints to identify root causes and implement appropriate corrective and preventive actions (CAPAs).- Knowledge of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant quality standards.- Making decisions on batch disposition and product recall based on root cause identification.- Reviewing and approving compliance reports following external (customer/regulatory) audits and corporate audits to ensure compliance.- Preparing and implementing quality assurance policies and procedures and ensure that standards and safety regulations are observed.- Timely completion of APQR related activity- Prepared & Review of Validation protocol and report (like Process Validation, Cleaning Validation, Analytical Method Validation,)- Handling of Market Complaint and Related Compliance- Handling of out of specification and suitable investigation- Handling of Deviation and Incident- Prepared BMR, SOP, Protocols etc.- Compliance of Vendor Audit, Regulatory Audit etc.Skills & QualificationEducation:UG: B.Sc / B.PharmPG: M.Sc / M. PharmKnowledge of computer competence, including database managementMinimum Experience Required: 1 - 3 YearCV Required

Key Responsibilities Review and update standard operating procedures (SOPs) to align with changing regulations and best practices. Documentation And Records Management Maintain and manage documentation related to quality assurance activities, including batch records, investigation reports, change controls, and validation documentation. Ensure accurate and timely completion of all quality-related documentation. Product Quality Control Investigate product non-conformances, deviations, and customer complaints to identify root causes and implement appropriate corrective and preventive actions (CAPAs). Knowledge of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant quality standards. Making decisions on batch disposition and product recall based on root cause identification. Reviewing and approving compliance reports following external (customer/regulatory) audits and corporate audits to ensure compliance. Preparing and implementing quality assurance policies and procedures and ensure that standards and safety regulations are observed. Timely completion of APQR related activity Prepared & Review of Validation protocol and report (like Process Validation, Cleaning Validation, Analytical Method Validation,) Handling of Market Complaint and Related Compliance Handling of out of specification and suitable investigation Handling of Deviation and Incident Prepared BMR, SOP, Protocols etc. Compliance of Vendor Audit, Regulatory Audit etc.Skills & QualificationEducation: UG: B.Sc / B.PharmPG: M.Sc / M. Pharm Knowledge of computer competence, including database managementMinimum Experience Required: 1 - 3 YearCV Required