Quality Analyst

Role & responsibilities

To perform Quality Control testing activities for pharmaceutical-grade rubber components used in sterile product packaging. The role involves ensuring that all raw materials, in-process, and finished goods comply with applicable pharmacopeial standards, internal quality specifications, and regulatory requirements.

Key Responsibilities:

1. Quality Control Testing:

• Conduct physical, chemical, and functional testing of rubber components (stoppers, plungers, seals, etc.) as per approved specifications and test methods.
  
• Perform visual inspection, dimensional analysis, hardness, tensile strength, and extractable/leachable testing.
  
• Ensure calibration, maintenance, and proper handling of laboratory instruments (e.g., Vernier Calipers, Tensile Strength Tester, FTIR, UV Spectrophotometer, HPLC, etc.).
  
• Maintain accurate test records, analytical data, and documentation in compliance with GDP and cGMP standards.
  

2. Vendor Site Quality Operations:

• Support vendor site quality activities related to batch testing, review, and batch release of rubber components.
  
• Conduct in-process inspections, sample collection, and verification of test results at vendor/manufacturing locations.
  
• Review vendor batch documents, certificates of analysis (CoA), and ensure conformance to specifications.
  
• Coordinate with vendor QC/QA teams for deviations, OOS, or non-conformance issues.
  

3. Batch Release & Documentation:

• Evaluate analytical results, review test reports, and recommend batches for release or rejection.
  
• Prepare batch release summaries and ensure timely communication with internal stakeholders.
  
• Support preparation and review of specifications, test methods, and SOPs related to QC testing of rubber components.
  

4. Compliance & Continuous Improvement:

• Ensure strict adherence to cGMP, GLP, and EHS guidelines at all times.
  
• Participate in internal audits, vendor audits, and regulatory inspections.
  
• Identify areas for quality improvement and assist in implementation of CAPA.
  
• Participate in validation and qualification of instruments, methods, and processes related to QC testing.
  

Required Skills & Competencies:

• Sound understanding of QC testing techniques for pharmaceutical rubber materials.
  
• Familiarity with pharmacopeial standards (USP, EP, IP) and regulatory guidelines for packaging components.
  
• Good documentation and reporting skills in line with GDP practices.
  
• Hands-on experience with analytical instruments and QC data handling.
  
• Excellent communication and vendor coordination skills.
  
• Ability to work independently at vendor sites and ensure timely batch release compliance.

Preferred candidate profile