Description
At Pfizer, you will play a crucial role in ensuring the quality of our products. As an Analytical Method Transfer and Validation Specialist, you will perform method transfers, validations, and verifications for complex analytical techniques. Your responsibilities will include interpreting and evaluating data for accuracy and recommending corrective actions, maintaining documentation and quality records, reviewing and revising Standard Operating Procedures, and conducting analyses on finished products, raw materials, and components.
Key Responsibilities:
- Perform method transfers, validations, and verifications for complex analytical techniques
- Interpret and evaluate data for accuracy, precision, trends, and potential cGMP impact
- Ensure documentation and quality records comply with Good Manufacturing Practices and Good Laboratory Practices
- Review and revise Standard Operating Procedures, analytical methods, and related documents
- Conduct analyses on finished products, raw materials, and components
- Contribute to project completion, manage time effectively, and develop plans for work activities within a team
Requirements:
- Master's degree in Chemistry or Pharmacy with 8-10 years of experience in Analytical Method Transfer/Validation
- Qualified in multiple analytical techniques, including HPLC, GC, IC, ICP-MS, Potentiometry, UV-Vis, FTIR, Karl Fischer, and pH meters
- Demonstrated technical skills in method validation and testing
- Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures, and governmental regulations
- Knowledge of ICH Q2 (R1/R2), USP, and EP standards
- Excellent organizational skills and strong ability to multi-task
- Strong written and verbal communication skills
Preferred Requirements:
- Experience with laboratory work, particularly using analytical HPLC, GC, IC, ICP-MS techniques
- Proven track record in leading continuous improvement projects
- Strong knowledge of lean manufacturing principles, six sigma methodologies, and statistical analysis
- Strong problem-solving skills and attention to detail
- Ability to manage multiple priorities and meet deadlines
- Excellent interpersonal skills and adaptability