INDORE · FULLTIME
Executive
Rubicon Research
Indore · onsite · Posted 24d ago
Sourced from
Not disclosed5–8 yrsfulltimeIndore
About a minute. You'll make an account on the way through.
agent · working
- Read this posting0.6s
- Found the form on Foundit · 9 questions to answer1.5s
- Decided the answers for all of them2.9s
- Tailor your résumé to this role
- Waiting for you
Section · 01
About this role
Purpose
To execute and support cleaning validation activities for manufacturing equipment, process equipment, utensils, and associated systems in compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and company procedures. The role is responsible for preparation and execution of cleaning validation protocols, sampling activities, documentation, investigation of validation deviations, and maintenance of the cleaning validation lifecycle.
Position / Job Title Executive
Department Quality Assurance – Cleaning validation
Reporting To Senior Manager- Quality Assurance
Location Pithampur
Years of Experience 5-8 Years
Dosage Form Solid Oral
Job Responsibilities / Deliverables
Cleaning Validation
Prepare, review, and execute Cleaning Validation Protocols and Reports for manufacturing equipment, utensils, and ancillary equipment.
Perform risk assessment for equipment grouping, product matrixing, and worst-case product selection.
Support development and maintenance of the Cleaning Validation Master Plan.
Ensure cleaning validation activities comply with approved protocols and procedures.
Sampling Activities
Perform or coordinate swab and rinse sampling following validated sampling procedures.
Ensure correct identification, handling, storage, and transfer of validation samples to the Quality Control laboratory.
Verify sampling locations based on equipment design and worst-case considerations.
Validation Execution
Coordinate execution of cleaning validation studies with Production, Quality Control, and Engineering departments.
Verify equipment cleanliness before validation execution.
Ensure required documentation is completed accurately during validation activities.
Acceptance Criteria
Verify Cleaning Validation Acceptance Criteria Based On
Health-based exposure limits (HBEL/PDE), where applicable.
Maximum Allowable Carryover (MACO).
Visual cleanliness.
Analytical acceptance criteria.
Microbiological acceptance criteria, where applicable.
Documentation
Prepare and maintain validation protocols, reports, summary reports, and associated documentation.
Ensure documentation complies with Good Documentation Practices (GDP) and ALCOA+ Data Integrity principles.
Maintain cleaning validation schedules and validation status records.
Investigation and CAPA
Participate in investigations related to cleaning validation failures, deviations, out-of-limit results, and revalidation activities.
Assist in root cause analysis and implementation of Corrective and Preventive Actions (CAPA).
Support change control assessments related to cleaning processes and equipment.
Periodic Review and Revalidation
Support periodic review of validated cleaning procedures.
Recommend revalidation following equipment modification, product change, cleaning process changes, or regulatory requirements.
Cross-Functional Coordination
Coordinate with Production, Quality Control, Engineering, Maintenance, and Quality Assurance for planning and execution of validation activities.
Ensure timely completion of validation activities to support manufacturing schedules.
Audit Support
Support internal audits, customer audits, and regulatory inspections by providing cleaning validation documentation and technical explanations.
Assist in responding to audit observations related to cleaning validation.
Additional Job Responsibility
change request evaluation with respect to change in API, manufacturing process, equipment cleaning procedure, change in equipment train
Risk assessment with respect to change in cleaning process, new equipment introduction,
GAP assessment with respect to current regulatory requirement
Ensure all QMS are closed as per SOP timeline.
Review of calibration activity as per defined schedule frequency.
Review of preventive maintenance activity as per defined frequency.
Review of requalification activity as per defined frequency.
Preparation and review of QA department SOPs.
Good knowledge about current trends of Data integrity.
Good knowledge about current Regulatory Guidance and requirement
Qualifications & Pre-requisites
Must-Have Skills: B Pharmacy/ M. Pharmacy
Must have knowledge on handling Qualification and validation.
Exposure to various regulatory bodies like US FDA, MHRA, TGA.
Exposure to specific dosage forms like OSD.
Team coordination and work distribution.
Good communication skill which results to coordination with functions like QC, Manufacturing, Engineering, Warehouse Regulatory.
To execute and support cleaning validation activities for manufacturing equipment, process equipment, utensils, and associated systems in compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and company procedures. The role is responsible for preparation and execution of cleaning validation protocols, sampling activities, documentation, investigation of validation deviations, and maintenance of the cleaning validation lifecycle.
Position / Job Title Executive
Department Quality Assurance – Cleaning validation
Reporting To Senior Manager- Quality Assurance
Location Pithampur
Years of Experience 5-8 Years
Dosage Form Solid Oral
Job Responsibilities / Deliverables
Cleaning Validation
Prepare, review, and execute Cleaning Validation Protocols and Reports for manufacturing equipment, utensils, and ancillary equipment.
Perform risk assessment for equipment grouping, product matrixing, and worst-case product selection.
Support development and maintenance of the Cleaning Validation Master Plan.
Ensure cleaning validation activities comply with approved protocols and procedures.
Sampling Activities
Perform or coordinate swab and rinse sampling following validated sampling procedures.
Ensure correct identification, handling, storage, and transfer of validation samples to the Quality Control laboratory.
Verify sampling locations based on equipment design and worst-case considerations.
Validation Execution
Coordinate execution of cleaning validation studies with Production, Quality Control, and Engineering departments.
Verify equipment cleanliness before validation execution.
Ensure required documentation is completed accurately during validation activities.
Acceptance Criteria
Verify Cleaning Validation Acceptance Criteria Based On
Health-based exposure limits (HBEL/PDE), where applicable.
Maximum Allowable Carryover (MACO).
Visual cleanliness.
Analytical acceptance criteria.
Microbiological acceptance criteria, where applicable.
Documentation
Prepare and maintain validation protocols, reports, summary reports, and associated documentation.
Ensure documentation complies with Good Documentation Practices (GDP) and ALCOA+ Data Integrity principles.
Maintain cleaning validation schedules and validation status records.
Investigation and CAPA
Participate in investigations related to cleaning validation failures, deviations, out-of-limit results, and revalidation activities.
Assist in root cause analysis and implementation of Corrective and Preventive Actions (CAPA).
Support change control assessments related to cleaning processes and equipment.
Periodic Review and Revalidation
Support periodic review of validated cleaning procedures.
Recommend revalidation following equipment modification, product change, cleaning process changes, or regulatory requirements.
Cross-Functional Coordination
Coordinate with Production, Quality Control, Engineering, Maintenance, and Quality Assurance for planning and execution of validation activities.
Ensure timely completion of validation activities to support manufacturing schedules.
Audit Support
Support internal audits, customer audits, and regulatory inspections by providing cleaning validation documentation and technical explanations.
Assist in responding to audit observations related to cleaning validation.
Additional Job Responsibility
change request evaluation with respect to change in API, manufacturing process, equipment cleaning procedure, change in equipment train
Risk assessment with respect to change in cleaning process, new equipment introduction,
GAP assessment with respect to current regulatory requirement
Ensure all QMS are closed as per SOP timeline.
Review of calibration activity as per defined schedule frequency.
Review of preventive maintenance activity as per defined frequency.
Review of requalification activity as per defined frequency.
Preparation and review of QA department SOPs.
Good knowledge about current trends of Data integrity.
Good knowledge about current Regulatory Guidance and requirement
Qualifications & Pre-requisites
Must-Have Skills: B Pharmacy/ M. Pharmacy
Must have knowledge on handling Qualification and validation.
Exposure to various regulatory bodies like US FDA, MHRA, TGA.
Exposure to specific dosage forms like OSD.
Team coordination and work distribution.
Good communication skill which results to coordination with functions like QC, Manufacturing, Engineering, Warehouse Regulatory.
Sourced from foundit
Section · 02
Skills
Team CoordinationAnalytical acceptance criteriaMicrobiological acceptance criteriacleaning validationAudit SupportRisk Assessmentvalidation protocolsSampling ProceduresQualification and validationchange control assessments
Section · Company
About Rubicon Research
Rubicon Research
Pharma
1.1k+
employees
1999
27 years old
Atlanta,Georgia
United States
About
Rubicon has built and expanded on strong strategic partnerships primarily regarding Development, Manufacturing, and Regulatory Support of Pharmaceutical Products.
Industries
PharmaInternet
Employee ratings
375 reviews
3.4/ 5
Culture
3.2
Career growth
3.0
Work-life
3.1
Employees rate it well for
Work Culture34Senior Management28Learning26Salary25HR Policies23
Find them on