Analytical QA - Officer to Asst Manager

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 outofspecification 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 crossfunctional 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.
     

Requirements

Qualifications:

• Bachelors or Masters 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 problemsolving.