IPQA GI - Halol, India - Job Excel

Description

Responsibilities:

1. IPQAOfficer for GeneralInjectables:
   • Performinprocess quality checks during manufacturing and packaging ofgeneral injectable products.
     
   • Conductline clearance and equipment checks to ensure compliance withStandard Operating Procedures(SOPs).
     
   • Monitor critical processparameters and perform sampling for analysis as per approvedsampling plans.
     
   • Review batch recordsand document observations related to inprocess qualitychecks.
     
   • Assist in investigations ofdeviations nonconformances and root cause analysis related togeneral injectablesproduction.
     
2. SeniorExecutive for GeneralInjectables:
   • Oversee IPQAactivities for general injectable products and ensure adherence tocGMP guidelines and regulatoryrequirements.
     
   • Provide guidance andsupport to IPQA Officers in conducting inprocess quality checks andresolving issues effectively.
     
   • Reviewand approve SOPs batch records and other qualityrelated documentsfor general injectablesmanufacturing.
     
   • Lead investigationsinto complex quality incidents and deviations ensuring timelyresolution and CAPAimplementation.
     
   • Collaborate withcrossfunctional teams to implement process improvements andoptimize manufacturingefficiency.
     
3. AssistantManager for GeneralInjectables:
   • Manage the IPQAteam for general injectable products and allocate resourcesefficiently to meet qualityobjectives.
     
   • Develop and implementstrategies to enhance IPQA processes including riskbased approachesand continuous improvementinitiatives.
     
   • Represent IPQA ininternal and external audits regulatory inspections and clientmeetings related to generalinjectables.
     
   • Conduct trainingsessions for IPQA staff to ensure competency and compliance withquality standards.
     
   • Participate inthe development and revision of quality policies procedures andguidelines for generalinjectables.
     
4. DeputyManager for GeneralInjectables:
   • Providestrategic direction and leadership in IPQA activities for generalinjectable products ensuring alignment with company goals andobjectives.
     
   • Drive a culture ofquality excellence and continuous improvement within the IPQA teamand across manufacturingoperations.
     
   • Act as a key point ofcontact for resolving escalated quality issues and providing expertguidance on IPQA matters.
     
   • Leadcrossfunctional initiatives to implement best practices streamlineprocesses and enhance overall product quality for generalinjectables.
     
   • Collaborate with seniormanagement to develop longterm strategies and initiatives forimproving IPQA performance andcompliance.
     
5. Managerfor GeneralInjectables:
   • Oversee theoverall IPQA function for general injectable products includingstrategy development implementation and performancemonitoring.
     
   • Ensure effectiveresource allocation talent development and succession planningwithin the IPQA team.
     
   • Drivestrategic initiatives to enhance manufacturing efficiency reducequality risks and achieve operational excellence in generalinjectables production.
     
   • Serve as asubject matter expert in IPQA for general injectables providingguidance to senior management and otherstakeholders.
     
   • Represent the companyin industry forums regulatory interactions and qualityrelatedinitiatives related to generalinjectables.
     

Requirements

Qualifications:

• Bachelorsor Masters degree in Pharmacy Chemistry or related field.Additional qualifications in Quality Assurance or PharmaceuticalSciences arepreferred.
  
• years ofexperience in pharmaceutical manufacturing with specific experiencein InProcess Quality Assurance for injectableproducts.
  
• Thorough understanding ofcGMP guidelines and regulatory requirements applicable topharmaceutical manufacturing (e.g. USFDA ROW EU CDT EMAICH).
  
• Strong analytical skillsattention to detail and ability to troubleshoot manufacturingprocesses effectively.
  
• Excellentcommunication leadership and teamwork skills with the ability tocollaborate effectively across departments andfunctions.
  

Responsibilities: IPQA Officer for General Injectables: Performin-process quality checks during manufacturing and packaging ofgeneral injectable products. Conduct line clearance and equipmentchecks to ensure compliance with Standard Operating Procedures(SOPs). Monitor critical process parameters and perform samplingfor analysis as per approved sampling plans. Review batch recordsand document observations related to in-process quality checks.Assist in investigations of deviations, non-conformances, and rootcause analysis related to general injectables production. SeniorExecutive for General Injectables: Oversee IPQA activities forgeneral injectable products and ensure adherence to cGMP guidelinesand regulatory requirements. Provide guidance and support to IPQAOfficers in conducting in-process quality checks and resolvingissues effectively. Review and approve SOPs, batch records, andother quality-related documents for general injectablesmanufacturing. Lead investigations into complex quality incidentsand deviations, ensuring timely resolution and CAPA implementation.Collaborate with cross-functional teams to implement processimprovements and optimize manufacturing efficiency. AssistantManager for General Injectables: Manage the IPQA team for generalinjectable products and allocate resources efficiently to meetquality objectives. Develop and implement strategies to enhanceIPQA processes, including risk-based approaches and continuousimprovement initiatives. Represent IPQA in internal and externalaudits, regulatory inspections, and client meetings related togeneral injectables. Conduct training sessions for IPQA staff toensure competency and compliance with quality standards.Participate in the development and revision of quality policies,procedures, and guidelines for general injectables. Deputy Managerfor General Injectables: Provide strategic direction and leadershipin IPQA activities for general injectable products, ensuringalignment with company goals and objectives. Drive a culture ofquality excellence and continuous improvement within the IPQA teamand across manufacturing operations. Act as a key point of contactfor resolving escalated quality issues and providing expertguidance on IPQA matters. Lead cross-functional initiatives toimplement best practices, streamline processes, and enhance overallproduct quality for general injectables. Collaborate with seniormanagement to develop long-term strategies and initiatives forimproving IPQA performance and compliance. Manager for GeneralInjectables: Oversee the overall IPQA function for generalinjectable products, including strategy development,implementation, and performance monitoring. Ensure effectiveresource allocation, talent development, and succession planningwithin the IPQA team. Drive strategic initiatives to enhancemanufacturing efficiency, reduce quality risks, and achieveoperational excellence in general injectables production. Serve asa subject matter expert in IPQA for general injectables, providingguidance to senior management and other stakeholders. Represent thecompany in industry forums, regulatory interactions, andquality-related initiatives related to general injectables.Requirements Qualifications: years of experience in pharmaceuticalmanufacturing, with specific experience in In-Process QualityAssurance for injectable products. Thorough understanding of cGMPguidelines and regulatory requirements applicable to pharmaceuticalmanufacturing (e.g., USFDA, ROW, EU, CDT, EMA, ICH). Stronganalytical skills, attention to detail, and ability to troubleshootmanufacturing processes effectively. Excellent communication,leadership, and teamwork skills, with the ability to collaborateeffectively across departments and functions.