IPQA GI - Officer to Manager

Responsibilities:

1. IPQA Officer for General Injectables:

   • Perform inprocess quality checks during manufacturing and packaging of general injectable products.
     
   • Conduct line clearance and equipment checks to ensure compliance with Standard Operating Procedures (SOPs).
     
   • Monitor critical process parameters and perform sampling for analysis as per approved sampling plans.
     
   • Review batch records and document observations related to inprocess quality checks.
     
   • Assist in investigations of deviations nonconformances and root cause analysis related to general injectables production.
     

2. Senior Executive for General Injectables:

   • Oversee IPQA activities for general injectable products and ensure adherence to cGMP guidelines and regulatory requirements.
     
   • Provide guidance and support to IPQA Officers in conducting inprocess quality checks and resolving issues effectively.
     
   • Review and approve SOPs batch records and other qualityrelated documents for general injectables manufacturing.
     
   • Lead investigations into complex quality incidents and deviations ensuring timely resolution and CAPA implementation.
     
   • Collaborate with crossfunctional teams to implement process improvements and optimize manufacturing efficiency.
     

3. Assistant Manager for General Injectables:

   • Manage the IPQA team for general injectable products and allocate resources efficiently to meet quality objectives.
     
   • Develop and implement strategies to enhance IPQA processes including riskbased approaches and continuous improvement initiatives.
     
   • Represent IPQA in internal and external audits regulatory inspections and client meetings related to general injectables.
     
   • Conduct training sessions for IPQA staff to ensure competency and compliance with quality standards.
     
   • Participate in the development and revision of quality policies procedures and guidelines for general injectables.
     

4. Deputy Manager for General Injectables:

   • Provide strategic direction and leadership in IPQA activities for general injectable products ensuring alignment with company goals and objectives.
     
   • Drive a culture of quality excellence and continuous improvement within the IPQA team and across manufacturing operations.
     
   • Act as a key point of contact for resolving escalated quality issues and providing expert guidance on IPQA matters.
     
   • Lead crossfunctional initiatives to implement best practices streamline processes and enhance overall product quality for general injectables.
     
   • Collaborate with senior management to develop longterm strategies and initiatives for improving IPQA performance and compliance.
     

5. Manager for General Injectables:

   • Oversee the overall IPQA function for general injectable products including strategy development implementation and performance monitoring.
     
   • Ensure effective resource allocation talent development and succession planning within the IPQA team.
     
   • Drive strategic initiatives to enhance manufacturing efficiency reduce quality risks and achieve operational excellence in general injectables production.
     
   • Serve as a subject matter expert in IPQA for general injectables providing guidance to senior management and other stakeholders.
     
   • Represent the company in industry forums regulatory interactions and qualityrelated initiatives related to general injectables.
     

Requirements

Qualifications:

• Bachelors or Masters degree in Pharmacy Chemistry or related field. Additional qualifications in Quality Assurance or Pharmaceutical Sciences are preferred.
  
• years of experience in pharmaceutical manufacturing with specific experience in InProcess Quality Assurance for injectable products.
  
• Thorough understanding of cGMP guidelines and regulatory requirements applicable to pharmaceutical manufacturing (e.g. USFDA ROW EU CDT EMA ICH).
  
• Strong analytical skills attention to detail and ability to troubleshoot manufacturing processes effectively.
  
• Excellent communication leadership and teamwork skills with the ability to collaborate effectively across departments and functions.