Analytical QA

Responsibilities:

1. Analytical QA Officer:

   • Execute analytical quality assurance activities as per standard operating procedures (SOPs) and regulatory requirements.
     
   • Perform review and approval of analytical test methods, validation protocols, and reports.
     
   • Conduct audits and inspections of analytical laboratories to ensure compliance with cGMP regulations.
     
   • Assist in investigations of analytical deviations and out-of-specification results.
     
   • Support in the implementation of corrective and preventive actions (CAPAs) related to analytical testing.
     

2. Senior Executive:

   • Oversee analytical QA activities and provide guidance to the team in ensuring data integrity and compliance.
     
   • Review and approve analytical method validation and transfer protocols and reports.
     
   • Lead investigations into complex analytical issues and deviations, ensuring timely resolution.
     
   • Collaborate with cross-functional teams to address analytical challenges and optimize processes.
     
   • Participate in regulatory inspections and provide support during audits of analytical laboratories.
     

3. Assistant Manager:

   • Manage a team of analytical QA professionals and coordinate their activities to meet quality objectives.
     
   • Develop and implement strategies to enhance analytical quality systems and improve efficiency.
     
   • Serve as a subject matter expert in analytical method validation, equipment qualification, and laboratory compliance.
     
   • Lead continuous improvement initiatives to streamline analytical processes and enhance data integrity.
     
   • Provide training and mentorship to junior staff members to foster their professional growth.
     

Qualifications:

• Bachelor's or Master's degree in Pharmacy. Additional qualifications in Analytical Chemistry or Quality Assurance are preferred.
  
• Years of relevant experience in analytical quality assurance within the pharmaceutical industry.
  
• Thorough understanding of analytical techniques, instrumentation, and validation principles.
  
• Proficiency in regulatory requirements (e.g.,USFDA, ROW, EU, EMA, CTD,, ICH) and cGMP guidelines related to analytical testing.
  
• Strong analytical skills, attention to detail, and ability to troubleshoot analytical issues effectively.
  
• Excellent communication, leadership, and teamwork skills, with a proactive approach to problem-solving.