IPQA GI - Halol, India - Job Excel

Description

Responsibilities:

1. IPQA Officer for General Injectables:
   • Perform in-process 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 in-process quality checks.
     
   • Assist in investigations of deviations, non-conformances, 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 in-process quality checks and resolving issues effectively.
     
   • Review and approve SOPs, batch records, and other quality-related documents for general injectables manufacturing.
     
   • Lead investigations into complex quality incidents and deviations, ensuring timely resolution and CAPA implementation.
     
   • Collaborate with cross-functional 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 risk-based 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 cross-functional initiatives to implement best practices, streamline processes, and enhance overall product quality for general injectables.
     
   • Collaborate with senior management to develop long-term 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 quality-related initiatives related to general injectables.
     

Requirements

Qualifications:

• Bachelor's or Master's 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 In-Process 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.