Here Is What You Need (Minimum Requirements)
Master’s degree in chemistry/ pharmacy with 8-10 years of experience in Analytical Method Transfer / Validation)
Qualified in multiple analytical techniques (HPLC-with Empower, 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
Conduct analytical method validation in accordance with ICH Q2 (R1/R2), USP, and EP standards, encompassing protocol preparation, execution, approval of validation summaries, and coordination with cross‑functional teams.
Conduct test method GAP assessments against USP, EP, BP, and JP requirements for New Product Introduction (NPI).
Execute and document analytical method verification and method transfer activities.
Demonstrate knowledge of ICH Q9 (Quality Risk Management) and apply risk‑based principles for identifying, assessing, controlling, communicating, and reviewing quality risks throughout the product lifecycle.
Handling of OOS and OOT through QMS.
Perform identification, assay, purity, and related analytical tests using validated methods.
Monitor critical process parameters (CPPs) and critical quality attributes (CQAs).
Support process validation and troubleshooting activities; communicate analytical results promptly to Production and QA to ensure effective process control.
Manage working standards in compliance with established procedures.
Handle change control activities and ensure timely implementation and closure of related CAPA actions.
Knowledge of Good Manufacturing Practices and its application standards, processes, and policies.
Excellent organizational skills and strong ability to multi-task
Strong written and verbal communication skills
Proficiency with unique Quality Control instruments to meet accuracy specifications for sample management, retains management, interpretation, and evaluation
Bonus Points If You Have (Preferred Requirements)
Experience with laboratory work, particularly using analytical HPLC (High Pressure Liquid Chromatography),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 the ability to communicate effectively with colleagues at all levels
Adaptability and willingness to learn new techniques and procedures
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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Quality Assurance and Control
